FDA announced on August 1, 2008 the user fees for fiscal year 2009 (the U.S. government 2009 fiscal year start on October 1, 2008). The fees are based on PDUFA IV approved last year. The application fee for an application requiring clinical data is $1,247,200, for an application not requiring clinical data or a supplement [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, August 4th, 2008.
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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
KV’s DESI Guaifenesin Trumped by Adam’s 505(b)(2) Product
Published August 4th, 2008 in News Commentary. 0 CommentsLast week (7/30/2008) , FDA announced that it seized timed-release guaifenesin products from KV Pharmaceutical. In 2002 the FDA determined this DESI product to be a safety hazard to children. The manufacturers, including KV Pharmaceutical (Warning Letters: see page 23) were told to stop manufacturing by November 2003 unless they received NDA approval. Adams Respiratory Therapeutics obtained NDA [...]