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news.US-based NovaDel Pharma said that the FDA has accepted for filing its new drug application for ZolpiMist oral spray for the short-term treatment of insomnia.
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NovaDel has submitted its ZolpiMist (zolpidem tartrate) application using the FDA’s 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist with Ambien tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets.
The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines.