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You are currently browsing the Drug Kennel weblog archives for the day Thursday, March 18th, 2010.
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- Failed 505(b)(2)?: Vivus’ Qnexa
- Will We Have Generic User Fees? Public Meeting To Be Held.
- Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
- Generic Lovenox – 505j or 505(b)(2)
- New User Fees for 2011
- Still submitting paper ANDA applications?
- What should a license cost?
- Avandia: Who Won?
- Advisory Committee Meeting: Rosiglitazone
- The skinny on a potential new treatment of obesity
FDA Removes Unapproved Nitroglycerin Tablets
Published March 18th, 2010 in News Commentary. 0 CommentsOn March 16, 2010 FDA ordered Glenmark Generics and Konec to cease manufacturing and distribution of nitroglycerin tablets. These actions are part of the FDA program to remove unapproved products from the market. In this case, Pfizer makes the approved product, so these removed products can be thought of as unauthorized generics.