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You are currently browsing the Drug Kennel weblog archives for the day Monday, September 21st, 2009.
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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
More DESI Tannates removed from market
Published September 21st, 2009 in News Commentary. 0 CommentsFDA continues to remove unapproved DESI products from the market. Generally, it appears that the removals occur when the manufacturing site is inspected and the FDA identifies unapproved products being made. The latest manufacturer to be hit is ANIP Acquisition Company. During an inspection of the firms facilities in Gulfport, MS this past February, the [...]