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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, January 29th, 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
Oral Sleep-Aid Spray Approved Based on BE/Pharmacodynamic Studies
Published January 29th, 2008 in News Commentary. 0 CommentsNovaDel announced on January 23, 2008 that FDA accepted their 505(b)(2) filing for an oral spray ZolpiMist (TM). The reference listed drug is Ambien(R) Tablets. The press release indicated that the filing was based on ”two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics [...]