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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, September 23rd, 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
Another DESI in Discretion
Published September 23rd, 2008 in News Commentary. 0 CommentsEver since FDA gave notice about Marketed Unapproved Drugs, manufacturers of these drugs have been wondering when the shoe would drop on their products. Basically, the FDA has said that eventually these products must be removed from the market. Since the FDA does not have sufficient resources, it will remove products it deems most hazardous. [...]