Cadence Pharmaceuticals announced yesterday 5/14/2009 that it had submitted an NDA for Acetavance(TM) - intravenous acetaminophen. It is instructive to look at the clinical development plan for this 505(b)(2) product. According to the company, the FDA required 2 pivotal Phase 3 trials: one clinical trial for the treatment of acute pain in patients following orthopedic surgery [...]
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You are currently browsing the Drug Kennel weblog archives for the day Friday, May 15th, 2009.
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- Failed 505(b)(2)?: Vivus’ Qnexa
- Will We Have Generic User Fees? Public Meeting To Be Held.
- Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
- Generic Lovenox – 505j or 505(b)(2)
- New User Fees for 2011
- Still submitting paper ANDA applications?
- What should a license cost?
- Avandia: Who Won?
- Advisory Committee Meeting: Rosiglitazone
- The skinny on a potential new treatment of obesity
Quick-release bromocriptine mesylate approved
Published May 15th, 2009 in News Commentary. 0 CommentsThe FDA approved VeroScience’s Cycloset (bromocriptine mesylate) 0.8mg tablets on May 5 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The NDA was first submitted in 1997 - before the 505(b)(2) guidance. The API, bromocriptine mesylate was approved under NDA 017962 in 1978 as Parlodel in [...]