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You are currently browsing the Drug Kennel weblog archives for the day Thursday, February 5th, 2009.
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- Failed 505(b)(2)?: Vivus’ Qnexa
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- 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
2008 505(b)(2) Approvals
Published February 5th, 2009 in News Commentary. 0 CommentsFor the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively. The FDA publishes a list of drugs approved each year and this list for approvals through November, 2008 has a column [...]