The USFDA has completed the filing review for NDA's for oxycodone hydrochloride capsules, and liquid solution of Glenmark Generics Inc., USA. The NDA was submitted by GGI's partner Lehigh Valley Technologies (LVT). The US FDA in a letter to the company indicated that it has begun reviewing the application for oxycodone hydrochloride. Total sales for oxycodone hydrochloride capsules and liquid solution in the twelve month period ending December 2009 were USD 16 million as reported by IMS Health. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, once an NDA is accepted for filing, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA.
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