FDA Complete Response letter delays approval of J&J's carisbamate

28 August 2009

The US Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application for carisbamate, an anti-epileptic drug in development by Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals, thus delaying approval of the drug.

The NDA, filed in October 2008 by Johnson & Johnson Pharmaceutical Research and Development on behalf of Ortho-McNeil-Janssen Pharmaceuticals, seeks approval to market carisbamate (proposed trade name Comfyde) for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.

The company is currently evaluating the FDA's complete response letter, and will respond to the agency's questions as quickly as possible, but did not reveal any details of the FDA letter and requirements.

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