I have added a new page to this blog to track 505(b)(2) approvals. Please note the tab named Scorecard. It will be organized by calendar year. I am currently catching up on 2009 to date. Enjoy and give feedback when needed!
Archive for July, 2009
BDSI’s buccal fentanyl 505(b)(2) NDA approved
Published July 28th, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsBioDelivery Sciences International received FDA approval of its 505(b)(2) NDA for buccal fentanyl on July 16, 2009. Most notable about this approval is the first REMS (Risk Evaluation and Mitigation Strategies). The FDA cautioned that this REMS shouldn’t be used as an example for other opioid products. The reason is that the product is indicated [...]
AstraZeneca ends collaboration with MAP Pharmaceuticals
Published July 10th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsMAP Pharmaceuticals announced yesterday (7/9/09) that AstraZeneca has ended its collaboration on unit dose budesonide (UDB). This past February, MAP reported that the Phase 3 study had failed to reach its primary endpoints. Apparently, further analysis failed to support continued development of UDB. We seldom see failed 505(b)(2) development projects. This case is interesting because [...]
Benzyl Alcohol- NME approved under 505(b)(2)
Published July 9th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsThe source of NMEs (new molecular entities) for use in 505(b)(2) drug development programs is vast. A major benefit of an NME is the 5 year data exclusivity. Sciele Pharma recently (4/9/09) obtained 505(b)(2) approval for a 5% benzyl alcohol lotion for the treatment of head lice in patients 6 months of age and older. Benzyl alcohol is [...]
Colchicine Tablets Approved
Published July 31st, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsColchicine Tablets were approved by FDA on 7/29 & 7/30/09 (approval letters not yet posted as of this writing). Two NDA’s were submitted, one for the treatment of acute gout and the other for familial Mediterranean fever (FMF). Pretty amazing and interesting for a number of reasons. First, it is a DESI (meaning, a previously unapproved [...]