Saudi Government Bans Avandia (Georgia/Florida)

Saudi Arabia has suspended GlaxoSmithKline PLC's (GSK) diabetes drug Avandia for six months, saying the product's heart risks outweigh its benefits, but the U.K.-based drug maker said its stands by the controversial drug.

The Saudi Food and Drug Authority said on its website that the risk of using Avandia, also known as rosiglitazone, "outweighs its benefit, especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures."

It said safer alternatives could be used there instead.

Glaxo responded by saying "the Saudi regulatory authority action is based on a review that did not include the most recent scientific data on Avandia."

"GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label and maintains that this is an important medicine for the treatment of type 2 diabetes."

Glaxo now has six months to provide the Saudi drug regulator with evidence of why rosiglitazone and combination products containing it should not be taken off the Saudi market permanently. Rosiglitazone containing products marketed in Saudi Arabia are Avandia , Avandamet and Avandaryl.

http://online.wsj.com/article/BT-CO-20100322-710067.html?mod=WSJ_latestheadlines

FDA Orders Two Companies to Stop Marketing Unapproved Nitroglycerin Tablets

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The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.


From the FDA warning letter:

As labeled, the above products are drugs within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because they are intended to affect the structure or function of the body. Further, these drug products, as distributed by your firm, are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. Based upon our information, there are no FDA-approved applications on file for the above products. The marketing of these products without an approved application constitutes a violation of these provisions of the Act

Letters here:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204540.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204546.htm