The US FDA has completed the filing review for New Drug Applications (NDA's) for oxycodone hydrochloride capsules, and liquid solution of Glenmark Generics Inc., USA (GGI), the US subsidiary of Glenmark Generics Ltd (GGL). 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.
In light of FDA's recent initiative regarding "grandfathered/unapproved, products", that is, products manufactured and sold in the United States prior to the passage of the Food Drug and Cosmetic Act in 1938, Glenmark and LVT have taken a proactive approach towards this unapproved product and are working closely with the FDA to ensure successful and timely approval of the application.
In 2006, Glenmark and LVT entered into an exclusive partnership whereby LVT would manufacture both oral solid and liquid controlled substances for Glenmark to market and distribute in the United States. Over the course of this relationship Glenmark has successfully launched and gained market share for this basket of CII (Class II) products.