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You are currently browsing the Drug Kennel weblog archives for the day Friday, July 31st, 2009.
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- FDA Removes Unapproved Nitroglycerin Tablets
- FDA’s Determination of Vyvanse as NME Upheld
- FDA’s DAARP is now DAAP, DPAP is now DPARP
- Exalgo Approved
- Do Not Neglect Your Third-Party Drug Substance Manufacturer
- Proposed FDA rule would make Sponsors more responsible for data integrity - way more responsible
- Spending on DTC Ads
- Generic Approvals Taking Longer
- Can and Should ANDA Labeling Differ from the RLD?
- Roche’s Actemra Approved For RA After Year’s Delay
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 [...]