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You are currently browsing the Drug Kennel weblog archives for the day Thursday, July 9th, 2009.
Longer entries are truncated. Click the headline of an entry to read it in its entirety.
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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
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 [...]