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You are currently browsing the Drug Kennel weblog archives for the day Sunday, November 22nd, 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
EXAL-still-GO-ing
Published November 22nd, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsAt first, Monday’s (11/16/09) news from CombinatoRx said that the FDA had told the company “that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo™ under Section 505(b)(1)”. Then, on Friday (11/20/09), the company said that the FDA had extended the PDUFA review date by 3 [...]