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You are currently browsing the Drug Kennel weblog archives for the day Monday, May 4th, 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
Polypill: a 505(b)(2) candidate
Published May 4th, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsFDA approved Novartis’ Exforge HCT on April 30, 2009 for the second-line treatment of hypertension. Exforge, approved in 2007, contains the calcium channel blocker amlodipine and the angiotensin receptor blocker valsartan. The new product adds to Exforge the well known diuretic HCTZ - hydrochlorothiazide. The product was approved based on a single “8-week, multi-center, randomized, [...]