What a year for 505(b)(2) drug development! In 2011 FDA approved 44 505(b)(2) NDA submissions. Various authors have reported that FDA approved 34 or 35 drugs in 2011 (505(b)(1) NDA + BLA). I had speculated a couple of years ago that perhaps 80% of new drugs approved in 2012 would be 505(b)(2)’s, based on botha [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, January 9th, 2012.
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- 2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals
- What is an Approved DESI Product?
- Stability Changes coming to ANDAs
- Don’t launch unapproved products after 9/19/2011
- AB Rated 505(b)(2)’s
- 2012 PDUFA User Fees
- Whew! Supreme Court rules generic labels must track RLD
- KV’s Makena Part 4: Statistical versus Clinical Significance
- Patent Cliff Causes Pfizer Cuts
- Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products