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You are currently browsing the Drug Kennel weblog archives for the day Monday, March 9th, 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
505(b)(2) Development Risks
Published March 9th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsWe know that 505(b)(2) drug development is chosen because it is lower cost, lower risk and faster than traditional new drug development and offers the potential of greater ROI than generics. But, it is not without any risks.
On 3/06/2009, Takeda announced “that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 [...]