Health Canada warns consumers not to use certain lots of ReNu
MultiPlus contact lens solution due to potential health risk
- Consumer Information

Health Canada is warning consumers not to use Lots GC6038 and
GC6052 of the product ReNu MultiPlus contact lens solution
because they contain higher than expected amounts of iron that
could reduce the product’s effectiveness and cause serious eye
injury from infection. A recall of the affected lots from
wholesalers, retailers, distributors and eye care professionals
has been initiated by the manufacturer, Bausch and Lomb.

Consumers Advised To Avoid Raw Oysters Harvested from San Antonio Bay
The U.S. Food and Drug Administration (FDA) is investigating an outbreak of norovirus-associated illness linked to eating raw oysters harvested from San Antonio Bay, TX. FDA advises consumers to avoid eating raw oysters harvested from this area after February 1, 2007, as a result of reports of illnesses in people who attended a Maryland event where these oysters were served. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days.

Consumers who ate oyster products served in restaurants after February 1 and experienced symptoms of norovirus are encouraged to contact their healthcare provider and local health department. Consumers concerned about oysters purchased during this period should contact their place of purchase to determine if the oysters are from the affected lot of oysters.

To date, illnesses have been reported by 25 individuals who ate raw oysters over the weekend of February 9, 2007 – February 11, 2007 at a Bull & Oyster Event in Maryland. The Maryland Department of Health & Mental Hygiene’s test results from ill patients are positive for norovirus.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on February 24, 2007 and remain closed. Bayview Seafood, a distributor in Seadrift, TX, issued a voluntary recall on February 26, 2007. Another distributor, Rose Bay Oyster Company of Swanquarter, NC, issued a voluntary recall on February 28, 2007. Oysters subject to the recall were mislabeled by the Rose Bay Oyster Company, indicating Galveston Bay as the harvest area; the implicated oysters were actually harvested from San Antonio Bay. Oysters with tags that read: “Gal 1, 2/2/07” are subject to the recall.

FDA will continue working with health officials in Maryland to track any additional cases of norovirus illness. FDA will continue to provide regular updates to the public as this investigation unfolds.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

Cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. FDA advises that it’s always best to cook seafood thoroughly to minimize the risk of foodborne illness. Consumers can continue to enjoy oysters in many cooked preparations by following this advice:

At Restaurants and other Foodservice Establishments:

• Order oysters fully cooked.

In the Shell:

• Purchase oysters with the shells closed. Throw away any oysters with shells already opened.

To prepare oysters for eating, choose one of the following methods:

• Boil oysters until the shells open. Once open, boil for an additional 3-5 minutes.
• Steamer - add oysters to water that is already steaming and cook live oysters until the shells open; once open steam for another 4-9 minutes.
• Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to not get fully cooked.
• Discard any oysters that do not open during cooking.

Shucked Oysters:

To prepare oysters for eating, choose one of the following methods:

• Boil or simmer shucked oysters for at least 3 minutes or until the edges curl.
• Fry at 375 degrees for at least 3 minutes.
• Broil 3 inches from heat for 3 minutes.
• Bake at 450 degrees for 10 minutes.

Food Poisoning

As a follow-up to the recent Salmonella outbreak linked to peanut butter, the U.S. Food and Drug Administration (FDA) is informing consumers that ConAgra has extended their recall of all Peter Pan peanut butter, and all Great Value peanut butter beginning with product code 2111, including peanut butter toppings, back to October 2004. This information was obtained recently as part of the ongoing investigation being conducted by FDA.

Consumers who have purchased any of the products since October 2004 should discard them. FDA’s advice to consumers continues to be not to eat any Peter Pan peanut butter or any Great Value peanut butter beginning with the 2111 product code.

FDA will provide updates on recalled products, including any other products that may have been made with potentially contaminated peanut butter and distributed to consumers.

Symptoms of foodborne illness caused by Salmonella include fever, diarrhea and abdominal cramps. In persons with poor underlying health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections or death. Individuals who have recently eaten peanut butter-containing products from these companies and who have experienced any of these symptoms should contact their doctor or health care provider immediately and report the illnesses to their state or local health authorities. Similarly, institutional food establishments and other food service providers who have received reports of illness from consumers after they consumed a product containing this peanut butter are encouraged to share that information with their local health department.

FDA is continuing to work closely with the Centers for Disease Control and Prevention, and with states and local officials to identify how the contamination occurred in order to prevent similar foodborne illness outbreaks.

####

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We are pursuing individual Salmonella outbreak litigation nationwide and currently accepting new Peanut Butter recall food poisoning cases in all 50 states (as they become available). 

After you have received appropriate medical attention, you should contact us. You may be entitled to compensation for your injuries and we can help.

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Consumers Advised To Avoid Raw Oysters Harvested from San Antonio Bay

The U.S. Food and Drug Administration (FDA) is investigating an outbreak of norovirus-associated illness linked to eating raw oysters harvested from San Antonio Bay, TX. FDA advises consumers to avoid eating raw oysters harvested from this area after February 1, 2007, as a result of reports of illnesses in people who attended a Maryland event where these oysters were served. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days.

Consumers who ate oyster products served in restaurants after February 1 and experienced symptoms of norovirus are encouraged to contact their healthcare provider and local health department. Consumers concerned about oysters purchased during this period should contact their place of purchase to determine if the oysters are from the affected lot of oysters.

To date, illnesses have been reported by 25 individuals who ate raw oysters over the weekend of February 9, 2007 – February 11, 2007 at a Bull & Oyster Event in Maryland. The Maryland Department of Health & Mental Hygiene’s test results from ill patients are positive for norovirus.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on February 24, 2007 and remain closed. Bayview Seafood, a distributor in Seadrift, TX, issued a voluntary recall on February 26, 2007. Another distributor, Rose Bay Oyster Company of Swanquarter, NC, issued a voluntary recall on February 28, 2007. Oysters subject to the recall were mislabeled by the Rose Bay Oyster Company, indicating Galveston Bay as the harvest area; the implicated oysters were actually harvested from San Antonio Bay. Oysters with tags that read: “Gal 1, 2/2/07” are subject to the recall.

FDA will continue working with health officials in Maryland to track any additional cases of norovirus illness. FDA will continue to provide regular updates to the public as this investigation unfolds.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

Cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. FDA advises that it’s always best to cook seafood thoroughly to minimize the risk of foodborne illness. Consumers can continue to enjoy oysters in many cooked preparations by following this advice:

At Restaurants and other Foodservice Establishments:

* Order oysters fully cooked.

In the Shell:
* Purchase oysters with the shells closed. Throw away any oysters with shells already opened.

To prepare oysters for eating, choose one of the following methods:

* Boil oysters until the shells open. Once open, boil for an additional 3-5 minutes.
* Steamer - add oysters to water that is already steaming and cook live oysters until the shells open; once open steam for another 4-9 minutes.

* Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to not get fully cooked.

* Discard any oysters that do not open during cooking.

Shucked Oysters:

To prepare oysters for eating, choose one of the following methods:

* Boil or simmer shucked oysters for at least 3 minutes or until the edges curl.
* Fry at 375 degrees for at least 3 minutes.
* Broil 3 inches from heat for 3 minutes.
* Bake at 450 degrees for 10 minutes.

Source | Medpage Today

By Neil Osterweil, Senior Associate Editor, MedPage Today
March 02, 2007

The FDA has ordered 20 companies to stop marketing grandfathered prescription versions of the vasoconstrictor ergotamine tartrate, an old remedy for treatment of vascular headaches, including migraine. 

The agency’s complaint was outlined in warning letters to eight drug makers and 12 distributors. It hinges on the lack of approval and of proper package labeling on the older formulations which, while sold only by prescription, came on the market before changes to the Food, Drug, and Cosmetics Act required more thorough warning labels. 

Five FDA-approved ergotamine-containing products will remain on the market, albeit with a black-box warning against concomitant use of such products with drugs that potently inhibit the cytochrome p450 3A4 isoform (CYP 3A4), including some antifungal agents, protease inhibitors, and certain antibiotics. 

According to the FDA, mixing ergotamine-containing agents with CYP 3A4 inhibitors can lead to serious, life-threatening ischemia, including gangrene and death. Most of the unapproved versions of the drug don’t carry this warning, the agency noted. 

The letters give the companies 15 days to respond to the FDA with a description of their action plans, 60 days to stop manufacturing the drugs, and 180 days to stop manufacturing them, or face sanctions. 

“This action is the next step in an aggressive FDA initiative to insure that all marketed U.S. drugs have FDA approval,” said Michael Levy, of the FDA’s Center for Drug Evaluation and Research, in a briefing. 

The approved products that will remain on the market are: 

• Migergot suppository (marketed by G and W Labs) 
• Ergotamine Tartrate and Caffeine tablets (Mikart and West Ward) 
• Cafergot tablets (marketed by Sandoz) 
• Ergomar Sublingual tablets (marketed by Rosedale Therapeutics) 

“We are taking a sensible, risk-based approach to the problem, and remain dedicated to the goal of getting unapproved drugs off the market,” said Deborah M. Autor, CDER’s director of compliance. “Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval. We estimate that less than 2% of prescribed drugs are unapproved.” 

The companies ordered to pull their products from the market are welcome to present data to the agency proving that their products are safe and effective, at which point they can be considered for approval, Autor said in the briefing. 

The following companies have received the warning letters. 

• Actavis Totowa LLC 
• Anabolic Laboratories 
• Bio Pharm Inc. 
• Breckenridge Pharmaceutical Inc. 
• Centrix Pharmaceutical Inc. 
• DRX Pharmaceutical Consultants Inc. 
• DSC Laboratories 
• Excellium Pharmaceutical Inc. 
• Ferndale Laboratories Inc. 
• IVAX Pharmaceuticals Inc. (formerly Goldline Laboratories Inc.) 
• Kaiser Foundation Hospitals 
• Lini Inc. 
• Murfreesboro Pharmaceutical Nursing Supply 
• Nucare Pharmaceuticals Inc. 
• Qualitest Pharmaceuticals, Inc. 
• Sandoz Inc. 
• Superior Pharmaceutical Company 
• The Harvard Drug Group LLC (formerly Major Pharmaceuticals Inc.) 
• United Research Laboratories Inc. and Mutual Pharmaceutical Company 
• Vintage Pharmaceuticals Inc. 

WARNING LETTER

February 26, 2007

William S. Propst, Sr.
President and CEO
Vintage Pharmaceuticals Inc.
150 Vintage Drive
Huntsville, Alabama 35811

Dear Mr. Propst:

This letter is written in reference to the marketing by your firm of Bellaspas Tablets, a drug product containing ergotamine tartrate.

Drug products containing ergotamine that were marketed under new drug applications approved for safety only prior to 1962 were reviewed under the Drug Efficacy Study Implementation (DESI) program. On July 27, 1972, the Agency concluded that such products are new drugs effective for the treatment or prevention of “vascular headaches” (”e.g. migraine, migraine variants or `histaminic/> cephalalgia”‘) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355] and that approved new drug applications are required to market them. (37 Fed. Reg. 15032).

Under 21 C.F.R. § 310.6(b)(1), the ergotamine-containing product that you market is identical, related, or similar to the drugs reviewed in this DESI proceeding. Under 21 C.F.R. § 310.6(b)(2), the “new drug” determination made under this DESI proceeding applies to your product and therefore your product requires an approved new drug application before it may be lawfully sold. As there is no approved new drug application on file with the FDA for Bellaspas Tablets as marketed by your firm, the marketing of this product is in violation of sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], which prohibit the introduction or delivery for introduction into interstate commerce of a new drug without an approved new drug application.

Moreover, Bellaspas Tablets is a prescription drug within the meaning of section 503(b)(1) of the Act, [21 U.S.C. § 353(b)(1)], because it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. By definition, a prescription drug’s directions for use are not adequate to enable a layperson to safely use the drug for its intended uses. See 21 C.F.R. § 201.5. Consequently, Bellaspas Tablets labeling fails to bear adequate directions for use under section 502(f)(1) of the Act, [21 U.S.C. § 352(fl(1)]. Because it lacks an approved application, it is not exempt from this requirement under 21 C.F.R. § 201.115. Bellaspas Tablets is therefore misbranded.

Further, we note that FDA has reviewed and approved several ergotamine-containing drug products and determined that such products require warning information to be placed in a prominently displayed box pursuant to 21 C.F.R. § 201.57. This boxed warning is required to prevent use of potent CYP 3A4 inhibitors with ergotamine-containing products. Serious and/or life-threatening ischemia, including fatalities and cases of gangrene, has resulted from such concomitant use. Examples of potent CYP 3A4 inhibitors include: protease inhibitors, macrolide antibiotics, and antifungal agents. Your failure to display this warning regarding concomitant use of Bellaspas Tablets CYP 3A4 inhibitors also renders t11e product misbranded under section 502(f)(2) of the Act, [21 U.S.C. § 352(f)(2)], because its labeling fails to bear adequate warnings.

In addition to the serious health concern presented by your omission of this important warning, unapproved drugs are a public health risk in general because they may not meet modern standards for safety, effectiveness, quality, and labeling. Even though some ergotamine products were found to be effective for certain indications via the DESI process, this does not necessarily mean that Bellaspas Tablets as currently formulated, manufactured, and labeled, is effective or safe.

The above identified violations are not intended to be an all inclusive list of violations involving your facility. It is your responsibility to assure that your firm is in compliance with all requirements of the Act. We request that you review all drug products that you are currently marketing to assure they are in compliance with the Act and FDA regulations. If you no longer market any ergotamine-containing drug products or believe that you have received this letter in error, please notify the Agency at the address below.

As described in the guidance entitled “Marketed Unapproved Drugs - Compliance Policy Guide” (”Marketed Unapproved Drugs CPG”), the Agency may exercise its enforcement discretion and identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved drug. http://www.fda.gov/cder/guidance/6911fnl.pdf. The Agency intends to exercise its enforcement discretion with regard to unapproved, ergotamine- containing drug products as follows. FDA does not intend to initiate enforcement actions related to currently manufactured unapproved ergotamine-containing products if those products are listed with FDA under section 510 of the Act, [21 U.S.C. § 360], as of the date of this letter, unless the manufacturing of those products continues after April 27, 2007. Further, FDA does not intend to initiate enforcement actions related to the shipment in interstate commerce of unapproved ergotamine- containing products made by such firms, including Bellaspas Tablets, unless they are still being shipped on or after August 25, 2007 1.

You should be aware that the Agency does not intend to exercise its enforcement discretion as described in this letter in the following circumstances: (1) if a firm is violating other provisions of the Act; (2) when it appears that a firm, in response to this letter, increases its manufacture or distribution of unapproved ergotamine drug products above its usual volume during these periods; (3) if FDA learns of new information regarding any serious health risk or hazards associated with an unapproved ergotamine drug product; or (4) if a firm marketing unapproved ergotamine products does not undertake appropriate corrective action to cease marketing the products.
To avail your firm of these periods during which the Agency intends to exercise enforcement discretion regarding unapproved ergotamine products, you must reply within fifteen (15) days of your receipt of this letter with a commitment to comply with the conditions stated above. Please include:

• a statement(s) of what action you plan to take to comply;
• a statement of the amount of Bellaspas Tablets, and any other unapproved ergotamine-containing product, that is (are) in inventory under your control;
• the time period in which you expect such inventory to be exhausted, in its entirety, and your plan for disposition of any inventory remaining after the above shipment cessation date; and
• an estimate of when products in distribution channels will become exhausted.

If FDA receives your commitment within fifteen (15) days of your receipt of this letter, the agency intends to exercise its enforcement discretion as described above, unless the circumstances listed above or lack of compliance with the conditions set forth in this letter warrant further action . If FDA does not receive a commitment within fifteen (15) days of receipt of this letter or a firm or person fails to comply with the stop manufacture or stop shipment date, the agency may take immediate regulatory action, including but not limited to seizure and/or injunction. If FDA takes action, to preserve limited agency resources, FDA may also take simultaneous enforcement action relating to any other unapproved new drugs manufactured, distributed, or shipped by the defendant. (See, e.g., United States v. Sage Pharmaceuticals, 210 F.3d 475, 479-480 (5th Cir. 2000) (the agency can combine all violations of the act in one proceeding, rather than taking action against a firm with multiple violations of the act in “piecemeal fashion”).)

In addition, FDA cautions firms against reformulating their products into ergotamine-free unapproved new drugs that are marketed under the same name or substantially the same name (including a new name that contains the old name). In the Marketed Unapproved Drugs CPG, FDA states that it intends to give higher priority to enforcement actions involving unapproved drugs that are reformulated to evade an FDA enforcement action. In addition, reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients .

Please send your reply via fax, as well as mail or overnight delivery to: Valerie L. Whipp, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of New Drugs and Labeling Compliance, 11919 Rockville Pike, HFD-310, Rockville, MD 20852, fax number (301) 827-8904.

For information regarding the drug approval process see www.fda.gov/cder/regulatory/applications/default.htm
Should you wish to seek approval for your ergotamine product, you may contact Sally Loewke, MD, the Agency’s unapproved drugs coordinator at (301) 796-0710, who can help you identify the appropriate review division or office for further direction. However, until such time as you have FDA approval for your product, you must comply with this letter.

Sincerely yours,

/S/

Michael Levy
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

WARNING LETTER

February 26, 2007

Richard H. Roberts, M.D., Ph.D.

President and CEO
United Research Laboratories Inc . and Mutual Pharmaceutical Company
1100 Orthodox Street
Philadelphia, Pennsylvania 19124
Dear Dr. Roberts:

This letter is written in reference to the marketing by your firm of Bel-Tabs tablets, a drug product containing ergotamine tartrate.
Drug products containing ergotamine that were marketed under new drug applications approved for safety only prior to 1962 were reviewed under the Drug Efficacy Study Implementation (DESI) program. On July 27, 1972, the Agency concluded that such products are new drugs effective for the treatment or prevention of “vascular headaches” (”e.g. migraine, migraine variants or `histaminic cephalalgia”‘) subject to section 505 of’ the Federal Food, Drug, and Cosmetic Act (the Act) [21U.S.C. § 355] and that approved new drug applications are required to market them. (37 Fed. Reg. 15032).

Under 21 C.F.R. § 310.6(b)(1), the ergotamine-containing product that you market is identical, related, or similar to the drugs reviewed in this DESI proceeding. Under 21 C.F.R. § 310.6(b)(2), the “new drug” determination made under this DESI proceeding applies to your product and therefore your product requires an approved new drug application before it maybe lawfully sold. As there is no approved new drug application on file with the FDA for Bel-Tabs tablets as marketed by your firm, the marketing of this product is in violation of sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], which prohibit the introduction or delivery for introduction into interstate commerce of a new drug without an approved new drug application.
Moreover, Bel-Tabs tablets is a prescription drug within the meaning of section 503(b)(1) of the Act, [21 U.S.C. § 353(b)(1)], because it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. By definition, a prescription drug’s directions for use are not adequate to enable a layperson to safely use the drug for its intended uses. See 21 C.F.R. § 201.5. Consequently, Bel-Tabs tablets’ labeling fails to bear adequate directions for use under section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. Because it lacks an approved application, it is not exempt from this requirement under 21 C.F.R. § 201.115. Bel-Tabs tablets is therefore misbranded.

Further, we note that FDA has reviewed and approved several ergotamine-containing drug products nd determined that such products require warning information to be placed in a prominently displayed box pursuant to 21 C.F.R. § 201.57. This boxed warning is required to prevent use of potent CYP 3A4 inhibitors with ergotamine-containing products. Serious and/or life-threatening ischemia, including fatalities and cases of gangrene, has resulted from such concomitant use. Examples of potent CYP 3A4 inhibitors include: protease inhibitors, macrolide antibiotics, and antifungal agents. Your failure to display this warning regarding concomitant use of Bel-Tabs tablets with CYP 3A4 inhibitors also renders the product misbranded under section 502(f)(2) of the Act, [21 U.S.C. § 352(f)(2)], because its labeling fails to bear adequate warnings.

In addition to the serious health concern presented by your omission of this important warning, unapproved drugs are a public health risk in general because they may not meet modem standards for safety, effectiveness, quality, and labeling. Even though some ergotamine products were found to be effective for certain indications via the DESI process, this does not necessarily mean that Bel-Tabs tablets as currently formulated, manufactured, and labeled, is effective or safe.

The above identified violations are not intended to be an all inclusive list of violations involving your facility. It is your responsibility to assure that your firm is in compliance with all requirements of the Act.

We request that you review all drug products that you are currently marketing to assure they are in compliance with the Act and FDA regulations. If you no longer market any ergotamine-containing drug products or believe that you have received this letter in error, please notify the Agency at the address below.

As described in the guidance entitled “Marketed Unapproved Drugs - Compliance Policy Guide”(”Marketed Unapproved Drugs CPG”), the Agency may exercise its enforcement discretion and identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved drug. http://www.fda.gov/cder/guidance/6911fnl.pdf. Agency intends to exercise its enforcement discretion with regard to unapproved, ergotamine-containing drug products as follows. FDA does not intend to initiate enforcement actions related to currently manufactured unapproved ergotamine-containing products if those products are listed with FDA under section 510 of the Act, [21 U.S.C. § 360], as of the date of this letter, unless the manufacturing of those products continues after April 27, 2007. Further, FDA does not intend to initiate enforcement actions related to the shipment in interstate commerce of unapproved ergotamine-containing products made by such firms, including Bel-Tabs tablets, unless they are still being shipped on or after August 25, 2007 1.

You should be aware that the Agency does not intend to exercise its enforcement discretion as described in this letter in the following circumstances: (1) if a firm is violating other provisions of the Act; (2) when it appears that a firm, in response to this letter, increases its manufacture or distribution of unapproved ergotamine drug products above its usual volume during these periods; (3) if FDA learns of new information regarding any serious health risk or hazards associated with an unapproved ergotamine drug product; or (4) if a finn marketing unapproved ergotamine products does not undertake appropriate corrective action to cease marketing the products.

To avail your firm of these periods during which the Agency intends to exercise enforcement discretion regarding unapproved ergotamine products, you must reply within fifteen (15) days of your receipt of this letter with a commitment to comply with the conditions stated above. Please include:

• a statement(s) of what action you plan to take to comply;
• . a statement of the amount of Bel-Tabs tablets, and any other unapproved ergotamine-containing product, that is (are) in inventory under your control;
• the time period in which you expect such inventory to be exhausted, in its entirety,and your plan for disposition of any inventory remaining after the above shipment cessation date; and
• an estimate of when products in distribution channels will become exhausted.

If FDA receives your commitment within fifteen (15) days of your receipt of this letter, the agency intends to exercise its enforcement discretion as described above, unless the circumstances listed above or lack of compliance with the conditions set forth in this letter warrant further action. If FDA does not receive a commitment within fifteen (15) days of receipt of this letter or a firm or person fails to comply with the stop manufacture or stop shipment date, the agency may take immediate regulatory action, including but not limited to seizure and/or injunction. If FDA takes action, to preserve limited agency resources, FDA may also take simultaneous enforcement action relating to any other unapproved new drugs manufactured, distributed, or shipped by the defendant. (See, e.g., United States v. Sage Pharmaceuticals, 210 F3d 475, 479-480 (5th Cir. 2000) (the agency can combine all violations of the act in one proceeding, rather than taking action against a firm with multiple violations of the act in “piecemeal fashion”).)

In addition, FDA cautions firms against reformulating their products into ergotamine-free unapproved new drugs that are marketed under the same name or substantially the same name (including a new name that contains the old name). In the Marketed Unapproved Drugs CPG, FDA states that it intends to give higher priority to enforcement actions involving unapproved drugs that are reformulated to evade an FDA enforcement action. In addition, reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients.

Please send your reply via fax, as well as mail or overnight delivery to: Valerie L. Whipp, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of New Drugs and Labeling Compliance, 11919 Rockville Pike, HFD-310, Rockville, MD 20852, fax number (301)827-8904.

For information regarding the drug approval process see www.fda.gov/cder/regulatory/applications/default.htm. Should you wish to seek approval for your ergotamine product, you may contact Sally Loewke, MD, the Agency’s unapproved drugs coordinator at (301) 796-0710, who can help you identify the appropriate review division or office for further direction. However, until such time as you have FDA approval for your product, you must comply with this letter.

Sincerely yours,
/S/
Michael Levy
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

WARNING LETTER

February 26, 2007

Jay Levine
President and CEO
The Harvard Drug Group LLC (formerly Major Pharmaceuticals Inc .)
31778 Enterprise Drive
Livonia, Michigan 48150

Dear Mr. Levine:

This letter is written in reference to the marketing by your firm of drug products containing ergotamine tartrate, specifically, Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine,ergotamine, and pentobarbital suppositories.

Drug products containing ergotamine that were marketed under new drug applications approved for safety only prior to 1962 were reviewed under the Drug Efficacy Study Implementation (DESI) program. On July 27, 1972, the Agency concluded that such products are new drugs effective for the treatment or prevention of “vascular headaches” (”e.g. migraine, migraine variants or `histaminic cephalalgia”‘) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355] and that approved new drug applications are required to market them. (37 Fed. Reg. 15032).

Under 21 C.F.R. § 310.6(b)(1), the ergotamine-containing products that you market are identical,related, or similar to the drugs reviewed in this DESI proceeding. Under 21 C.F.R. § 310.6(b)(2), the “new drug” determination made under this DESI proceeding applies to your products and therefore your products require an approved new drug application before they may be lawfully sold. As there are no approved new drug applications on file with the FDA for any of the drug products, Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories as marketed by your firm, the marketing of these products is in violation of sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], which prohibit the introduction or delivery for introduction into interstate commerce of a new drug without an approved new drug application.

Moreover, Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories are prescription drugs within the meaning of section 503(b)(1) of the Act, [21 U.S.C. § 353(b)(1)], because they are not safe for use except under the supervision of a practitioner licensed bylaw to administer such drugs. By definition, a prescription drug’s directions for use are not adequate to enable a layperson to safely use the drug for its intended uses. See 21 C.F.R. § 201.5. Consequently, Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories’ labeling fail to bear adequate directions for use under section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. Because each lacks an approved application, each is not exempt from this requirement under 21 C.F.R. § 201.115. Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories are therefore misbranded.

Further, we note that FDA has reviewed and approved several ergotamine-containing drug products and determined that such products require warning information to be placed in a prominently displayed box pursuant to 21 C.F.R. § 201.57. This boxed warning is required to prevent use of potent CYP3A4 inhibitors with ergotamine-containing products. Serious and/or life-threatening ischemia, including fatalities and cases of gangrene, has resulted from such concomitant use. Examples of potent CYP 3A4 inhibitors include: protease inhibitors, macrolide antibiotics, and antifungal agents. Your failure to display this warning regarding concomitant use of Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories with CYP3A4 inhibitors also renders these products misbranded under section 502(f)(2) of the Act, [21 U.S.C. 352(fl(2)], because each product’s labeling fails to bear adequate warnings.

In addition to the serious health concern presented by your omission of this important warning, unapproved drugs are a public health risk in general because they may not meet modem standards for safety, effectiveness, quality, and labeling. Even though some ergotamine products were found to be effective for certain indications via the DESI process, this does not necessarily mean that Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories as currently formulated, manufactured, and labeled, are effective or safe.

The above identified violations are not intended to be an all inclusive list of violations involving your facility. It is your responsibility to assure that your firm is in compliance with all requirements of the Act. We request that you review all drug products that you are currently marketing to assure they are in compliance with the Act and FDA regulations. If you no longer market any ergotamine-containing drug products or believe that you have received this letter in error, please notify the Agency at the
address below.

As described in the guidance entitled “Marketed Unapproved Drugs - Compliance Policy Guide”(”Marketed Unapproved Drugs CPG”), the Agency may exercise its enforcement discretion and identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved drug. http://www.fda.gov/cder/guidance/6911fnl.pdf .The Agency intends to exercise its enforcement discretion with regard to unapproved, ergotamine-containing drug products as follows. FDA does not intend to initiate enforcement actions related to currently manufactured unapproved ergotamine-containing products if those products are listed with FDA under section 510 of the Act, [21 U.S.C. § 360], as of the date of this letter, unless the manufacturing of those products continues after April 27, 2007. Further, FDA does not intend to initiate enforcement actions related to the shipment in interstate commerce of unapproved ergotamine-containing products made by such firms, including Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories, unless they are still being shipped on or after August 25, 2007 1.

You should be aware that the Agency does not intend to exercise its enforcement discretion as described in this letter in the following circumstances: (1) if a firm is violating other provisions of the Act; (2) when it appears that a firm, in response to this letter, increases its manufacture or distribution of unapproved ergotamine drug products above its usual volume during these periods; (3) if FDA learns of new information regarding any serious health risk or hazards associated with an unapproved ergotamine drug product; or (4) if a firm marketing unapproved ergotamine products does not undertake appropriate corrective action to cease marketing the products.

To avail your firm of these periods during which the Agency intends to exercise enforcement discretion regarding unapproved ergotamine products, you must reply within fifteen (15) days of your receipt of this letter with a commitment to comply with the conditions stated above. Please include:

• a statement(s) of what action you plan to take to comply;
• a statement of the amount of each drug, Bellamine Tablets, Cafatine PB Tabs tablets, and caffeine, ergotamine, and pentobarbital suppositories, and any other unapproved ergotamine-containing product, that is (are) in inventory under your control;
• the time period in which you expect such inventory to be exhausted, in their entirety, and your plan for disposition of any inventory remaining after the above shipment cessation date; and
• an estimate of when products in distribution channels will become exhausted.

If FDA receives your commitment within fifteen (15) days of your receipt of this letter, the agency intends to exercise its enforcement discretion as described above, unless the circumstances listed above or lack of compliance with the conditions set forth in this letter warrant further action. If FDA does not receive a commitment within fifteen (15) days of receipt of this letter or a firm or person fails to comply with the stop manufacture or stop shipment date, the agency may take immediate regulatory action, including but not limited to seizure and/or injunction. If FDA takes action, to preserve limited agency resources, FDA may also take simultaneous enforcement action relating to any other unapproved new drugs manufactured, distributed, or shipped by the defendant. (See, e.g., United States v. Sage Pharmaceuticals, 210 F3d 475, 479-480 (5th Cir. 2000) (the agency can combine all violations of the act in one proceeding, rather than taking action against a firm with multiple violations of the act in “piecemeal fashion”).)

In addition, FDA cautions firms against reformulating their products into ergotamine-free unapproved new drugs that are marketed under the same name or substantially the same name (including a new name that contains the old name). In the Marketed Unapproved Drugs CPG, FDA states that it intends to give higher priority to enforcement actions involving unapproved drugs that are reformulated to evade an FDA enforcement action. In addition, reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients.

Please send your reply via fax, as well as mail or overnight delivery to: Valerie L. Whipp, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of New Drugs and Labeling Compliance, 11919 Rockville Pike, HFD-310, Rockville, MD 20852, fax number (301) 827-8904.

For information regarding the drug approval process see
www.fda.gov/cder/regulatory/applications/default.htm. Should you wish to seek approval for your ergotamine product, you may contact Sally Loewke, MD, the Agency’s unapproved drugs coordinator at (301) 796-0710, who can help you identify the appropriate review division or office for further direction. However, until such time as you have FDA approval for your product, you must comply with this letter.

Sincerely yours,

Michael Levy
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

WARNING LETTER

February 26, 2007

President and/or CEO
Superior Pharmaceutical Company
1385 Kemper Meadow Drive
Cincinnati, Ohio 45240

Dear Mr. or Ms. President and/or CEO:

This letter is written in reference to the marketing by your firm of Migracet-PB Suppositories, a drug product containing ergotamine tartrate.
Drug products containing ergotamine that were marketed under new drug applications approved for safety only prior to 1962 were reviewed under the Drug Efficacy Study Implementation (DESI) program. On July 27, 1972, the Agency concluded that such products are new drugs effective for the treatment or prevention of “vascular headaches” (”e.g. migraine, migraine variants or `histaminic cephalalgia”‘) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355] and that approved new drug applications are required to market them. (37 Fed. Reg. 15032).

Under 21 C.F.R. § 310.6(b)(1), the ergotamine-containing product that you market is identical, related, or similar to the drugs reviewed in this DESI proceeding. Under 21 C.F.R. § 310.6(b)(2), the”new drug” determination made under this DESI proceeding applies to your product and therefore your product requires an approved new drug application before it maybe lawfully sold. As there is no approved new drug application on file with the FDA for Migracet-PB Suppositories as marketed by your firm, the marketing of this product is in violation of sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], which prohibit the introduction or delivery for introduction into interstate commerce of a new drug without an approved new drug application.

Moreover, Migracet-PB Suppositories is a prescription drug within the meaning of section 503(b)(1)of the Act, [21 U.S.C. § 353(b)(1)], because it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. By definition, a prescription drug’s directions for use are not adequate to enable a layperson to safely use the drug for its intended uses. See 21 C.F.R. § 201.5. Consequently, Migracet-PB Suppositories’ labeling fails to bear adequate directions for use under section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. Because it lacks an approved application, it is not exempt from this requirement under 21 C.F.R. § 201.115. Migracet-PB Suppositories is therefore misbranded.

Further, we note that FDA has reviewed and approved several ergotamine-containing drug products and determined that such products require warning information to be placed in a prominently displayed box pursuant to 21 C.F.R. § 201.57. This boxed warning is required to prevent use of potent CYP 3A4 inhibitors with ergotamine-containing products. Serious and/or life-threatening ischemia, including fatalities and cases of gangrene, has resulted from such concomitant use. Examples of potent CYP 3A4 inhibitors include: protease inhibitors, macrolide antibiotics, and antifungal agents. Your failure to display this warning regarding concomitant use of Migracet-PB Suppositories with CYP3A4 inhibitors also renders the product misbranded under section 502(f)(2) of the Act, [21 U.S.C. § 352(f)(2)], because its labeling fails to bear adequate warnings.

In addition to the serious health concern presented by your omission of this important warning, unapproved drugs are a public health risk in general because they may not meet modern standards for safety, effectiveness, quality, and labeling. Even though some ergotamine products were found to be effective for certain indications via the DESI process, this does not necessarily mean that Migracet-PB Suppositories as currently formulated, manufactured, and labeled, is effective or safe.

The above identified violations are not intended to be an all inclusive list of violations involving your facility. It is your responsibility to assure that your firm is in compliance with all requirements of the Act. We request that you review all drug products that you are currently marketing to assure they are in compliance with the Act and FDA regulations. If you no longer market any ergotamine-containing drug products or believe that you have received this letter in error, please notify the Agency at the
address below.

As described in the guidance entitled “Marketed Unapproved Drugs -Compliance Policy Guide”(”Marketed Unapproved Drugs CPG”), the Agency may exercise its enforcement discretion and identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved. http://www.fda.gov/cder/guidance/6911fnl.pdf. The Agency intends to exercise its enforcement discretion with regard to unapproved, ergotamine-containing drug products as follows. FDA does not intend to initiate enforcement actions related to currently manufactured unapproved ergotamine-containing products if those products are listed with FDA under section 510 of the Act, [21 U.S.C. § 360], as of the date of this letter, unless the manufacturing of those products continues after April 27, 2007. Further, FDA does not intend to initiate enforcement actions related to the shipment in interstate commerce of unapproved ergotamine-containing products made by such firms, including Migracet-PB Suppositories, unless they are still being shipped on or after August 25, 2007 1.

You should be aware that the Agency does not intend to exercise its enforcement discretion as described in this letter in the following circumstances: (1) if a firm is violating other provisions of the Act; (2) when it appears that a firm, in response to this letter, increases its manufacture or distribution of unapproved ergotamine drug products above its usual volume during these periods; (3) if FDA learns of new information regarding any serious health risk or hazards associated with an unapproved ergotamine drug product; or (4) if a firm marketing unapproved ergotamine products does not undertake appropriate corrective action to cease marketing the products.

To avail your firm of these periods during which the Agency intends to exercise enforcement discretion regarding unapproved ergotamine products, you must reply within fifteen (15) days of your receipt of this letter with a commitment to comply with the conditions stated above. Please include:

• a statement(s) of what action you plan to take to comply;
• a statement of the amount of Migracet-PB Suppositories, and any other unapproved ergotamine-containing product, that is (are) in inventory under your control;
• the time period in which you expect such inventory to be exhausted, in its entirety, and your plan for disposition of any inventory remaining after the above shipment cessation date; and
• an estimate of when products in distribution channels will become exhausted.

If FDA receives your commitment within fifteen (15) days of your receipt of this letter, the agency intends to exercise its enforcement discretion as described above, unless the circumstances listed above or lack of compliance with the conditions set forth in this letter warrant further action. If FDA does not receive a commitment within fifteen (15) days of receipt of this letter or a firm or person fails to comply with the stop manufacture or stop shipment date, the agency may take immediate regulatory action, including but not limited to seizure and/or injunction. If FDA takes action, to preserve limited agency resources, FDA may also take simultaneous enforcement action relating to any other unapproved new drugs manufactured, distributed, or shipped by the defendant. (See, e.g., United States v. Sage Pharmaceuticals, 210 F3d 475, 479-480 (5th Cir. 2000) (the agency can combine all violations of the act in one proceeding, rather than taking action against a firm with multiple violations of the act in “piecemeal fashion”).)

In addition, FDA cautions firms against reformulating their products into ergotamine-free unapproved new drugs that are marketed under the same name or substantially the same name (including a new name that contains the old name). In the Marketed Unapproved Drugs CPG, FDA states that it intends to give higher priority to enforcement actions involving unapproved drugs that are reformulated to evade an FDA enforcement action. In addition, reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients.

Please send your reply via fax, as well as mail or overnight delivery to: Valerie L. Whipp, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of New Drugs and Labeling Compliance, 11919 Rockville Pike, HFD-310, Rockville, MD 20852, fax number (301) 827-8904.

For information regarding the drug approval process see
www.fda.gov/cder/regulatory/applications/default.htm. Should you wish to seek approval for your ergotamine product, you may contact Sally Loewke, MD, the Agency’s unapproved drugs coordinator at (301) 796-0710, who can help you identify the appropriate review division or office for further direction. However, until such time as you have FDA approval for your product, you must comply with this letter.

Sincerely yours,

/S/

Michael Levy
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

WARNING LETTER

February 26, 2007

Beth Brannan
c/o President or CEO
Sandoz Inc.
506 Carnegie Center Blvd, Ste. 400
Princeton, New Jersey 08540

Dear Ms. Brannan:

This letter is written in reference to the marketing by your firm of phenobarbital, ergotamine, and belladonna tablets, a drug product containing ergotamine tartrate.

Drug products containing ergotamine that were marketed under new drug applications approved for safety only prior to 1962 were reviewed under the Drug Efficacy Study Implementation (DESI) program. On July 27, 1972, the Agency concluded that such products are new drugs effective for the treatment or prevention of “vascular headaches” (”e.g. migraine, migraine variants or `histaminic cephalalgia”‘) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355] and that approved new drug applications are required to market them. (37 Fed. Reg. 15032).

Under 21 C.F.R. § 310.6(b)(1), the ergotamine-containing product that you market is identical,related, or similar to the drugs reviewed in this DESI proceeding. Under 21 C.F.R. § 310.6(b)(2), the “new drug” determination made under this DESI proceeding applies to your product and therefore your product requires an approved new drug application before it may be lawfully sold. As there is no approved new drug application on file with the FDA for phenobarbital, ergotamine, and belladonna tablets as marketed by your firm, the marketing of this product is in violation of sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], which prohibit the introduction or delivery for introduction into interstate commerce of a new drug without an approved new drug application.

Moreover, phenobarbital, ergotamine, and belladonna tablets is a prescription drug within the meaning 503(b)(1) of the Act, [21 U.S.C. § 353(b)(1)], because it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. By definition, a prescription drug’s directions for use are not adequate to enable a layperson to safely use the drug for its intended uses. See 21 C.F.R. § 201.5. Consequently, phenobarbital, ergotamine, and belladonna tablets’ labeling fails to bear adequate directions for use under section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. Because it lacks an approved application, it is not exempt from this requirement under 21 C.F.R. § 201.115. phenobarbital, ergotamine, and belladonna tablets is therefore misbranded.

Further, we note that FDA has reviewed and approved several ergotamine-containing drug products and determined that such products require warning information to be placed in a prominently displayed box pursuant to 21 C.F.R. § 201.57. This boxed warning is required to prevent use of potent CYP 3A4 inhibitors with ergotamine-containing products. Serious and/or life-threatening ischemia, including fatalities and cases of gangrene, has resulted from such concomitant use. Examples of potent CYP 3A4 inhibitors include: protease inhibitors, macrolide antibiotics, and antifungal agents. Your failure to display this warning regarding concomitant use of phenobarbital, ergotamine, and belladonna tablets with CYP 3A4 inhibitors also renders the product misbranded under section 502(f)(2) of the Act, [21 U.S.C. § 352(f)(2)], because its labeling fails to bear adequate warnings.

In addition to the serious health concern presented by your omission of this important warning,unapproved drugs are a public health risk in general because they may not meet modern standards for safety, effectiveness, quality, and labeling. Even though some ergotamine products were found to be effective for certain indications via the DESI process, this does not necessarily mean that phenobarbital, ergotamine, and belladonna tablets as currently formulated, manufactured, and labeled, is effective or safe.

The above identified violations are not intended to be an all inclusive list of violations involving your facility. It is your responsibility to assure that your firm is in compliance with all requirements of the Act. We request that you review all drug products that you are currently marketing to assure they are in compliance with the Act and FDA regulations. If you no longer market any ergotamine-containing drug products or believe that you have received this letter in error, please notify the Agency at the address below.

As described in the guidance entitled “Marketed Unapproved Drugs -Compliance Policy Guide” (”Marketed Unapproved Drugs CPG”), the Agency may exercise its enforcement discretion and identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved drug. http://www.fda.gov/cder/guidance/6911fnl.pdf. The Agency intends to exercise its enforcement discretion with regard to unapproved, ergotamine-containing drug products as follows. FDA does not intend to initiate enforcement actions related to currently manufactured unapproved ergotamine-containing products if those products are listed with FDA under section 510 of the Act, [21 U.S.C. § 360], as of the date of this letter, unless the manufacturing of those products continues after April 27, 2007. Further, FDA does not intend to initiate enforcement actions related to the shipment in interstate commerce of unapproved ergotamine-containing products made by such firms, including phenobarbital, ergotamine, and belladonna tablets, unless they are still being shipped on or after August 25, 2007 1.

You should be aware that the Agency does not intend to exercise its enforcement discretion as described in this letter in the following circumstances: (1) if a firm is violating other provisions of the Act; (2) when it appears that a firm, in response to this letter, increases its manufacture or distribution of unapproved ergotamine drug products above its usual volume during these periods; (3) if FDA learns of new information regarding any serious health risk or hazards associated with an unapproved ergotamine drug product; or (4) if a firm marketing unapproved ergotamine products does not undertake appropriate corrective action to cease marketing the products.

To avail your firm of these periods during which the Agency intends to exercise enforcement discretion regarding unapproved ergotamine products, you must reply within fifteen (15) days of your receipt of this letter with a commitment to comply with the conditions stated above. Please include:

• a statement(s) of what action you plan to take to comply;
• a statement of the amount of phenobarbital, ergotamine, and belladonna tablets, and any other unapproved ergotamine-containing product, that is (are) in inventory under your control;
• the time period in which you expect such inventory to be exhausted, in its entirety,and your plan for disposition of any inventory remaining after the above shipment cessation date; and
• an estimate of when products in distribution channels will become exhausted.

If FDA receives your commitment within fifteen (15) days of your receipt of this letter, the agency intends to exercise its enforcement discretion as described above, unless the circumstances listed above or lack of compliance with the conditions set forth in this letter warrant further action. If FDA does not receive a commitment within fifteen (15) days of receipt of this letter or a firm or person fails to comply with the stop manufacture or stop shipment date, the agency may take immediate regulatory action, including but not limited to seizure and/or injunction. If FDA takes action, to preserve limited agency resources, FDA may also take simultaneous enforcement action relating to any other unapproved new drugs manufactured, distributed, or shipped by the defendant. (See, e.g., United States v. Sage Pharmaceuticals, 210 F3d 475, 479-480 (5th Cir. 2000) (the agency can combine all violations of the act in one proceeding, rather than taking action against a firm with multiple violations of the act in “piecemeal fashion”).)

In addition, FDA cautions firms against reformulating their products into ergotamine-free unapproved new drugs that are marketed under the same name or substantially the same name (including a new name that contains the old name). In the Marketed Unapproved Drugs CPG, FDA states that it intends to give higher priority to enforcement actions involving unapproved drugs that are reformulated to evade an FDA enforcement action. In addition, reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients.

Please send your reply via fax, as well as mail or overnight delivery to: Valerie L. Whipp, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of New Drugs and Labeling Compliance, 11919 Rockville Pike, HFD-310, Rockville, MD 20852, fax number (301) 827-8904.

For information regarding the drug approval process see www.fda.gov/cder/regulatory/applications/default.htm
Should you wish to seek approval for your ergotamine product, you may contact Sally Loewke, MD, the Agency’s unapproved drugs coordinator at (301) 796-0710, who can help you identify the appropriate review division or office for further direction. However, until such time as you have FDA approval for your product, you must comply with this letter.

Sincerely yours,
/S/
Michael Levy
Director
Division of New Drugs and Labeling Compliance Office of Compliance
Center for Drug Evaluation and Research