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You are currently browsing the Drug Kennel weblog archives for the day Wednesday, April 1st, 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
FDA Stops DESI Unapproved Rx Narcotics
Published April 1st, 2009 in News Commentary. 0 CommentsYesterday, 3/31//09, FDA sent warning letters to nine pharmaceutical companies to stop manufacturing 14 unapproved narcotic drugs. These drugs are unapproved because they were made without NDA or ANDA approvals, falling under the category of DESI or grandfathered drugs.
Warning letters were sent to the following companies (I have listed the affected drug products for each [...]