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You are currently browsing the Drug Kennel weblog archives for the day Thursday, July 9th, 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
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 a [...]