Can you have an “AB” rated 505(b)(2)? Yes, as well as other Therapeutic Equivalent (TE) codes that are most often associated with the TE codes for generics in the Orange Book. Several years ago when I was speaking about the potential products that qualified under 505(b)(2) I had a line in a PowerPoint slide for [...]
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You are currently browsing the Drug Kennel weblog archives for the month September, 2011.
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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