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You are currently browsing the Drug Kennel weblog archives for the day Friday, May 29th, 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
MAP Pharmaceutials 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals
Published May 29th, 2009 in 505(b)(2) Process and News Commentary. 1 CommentMAP Pharmaceuticals recently reported good Phase 3 data on its new product in development, Levadex - dihydroergotamine (DHE) orally inhaled. DHE is an old drug that has been used for a long time as an injectable - a couple of generics exist. MAP says that their product is a new formulation and their website compares it [...]