Pharmaceuticals
FDA Issues Complete Response Letter for Carisbamate
Published in Medical Letter on the CDC and FDA, September 13th, 2009
The NDA, filed in October 2008 by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc. seeks approval to market carisbamate (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...
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