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You are currently browsing the Drug Kennel weblog archives for the day Friday, July 10th, 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
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 it [...]