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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, November 3rd, 2009.
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- 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
- News on the Biosimilar Front
- Pediatric Assessments in Drug Development: timing in Europe vs. US
FDA Refuse to File: Merck Zetia & Pfizer Lipitor
Published November 3rd, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsMerck disclosed that FDA refused to file its 505(b)(2) NDA for the combination of Pfizer’s Lipitor (atorvastatin) with Zetia (ezetimibe). According to Merck’s disclosure, the FDA reason for he refusal is:
The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA’s response in order to determine a [...]