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news.Carisbamate, for the adjunctive treatment of partial onset seizures in patients 16 years of age and older
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Ortho-McNeil-Janssen has reported that the FDA has issued a complete response letter regarding its New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development.
The NDA was filed in October 2008 by Johnson & Johnson (J&JPRD) on behalf of Ortho-McNeil-Janssen. The company seeks approval to market carisbamate for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.
The company said that it is currently evaluating the FDA’s complete response letter, and will respond to the agency’s questions as quickly as possible.
Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson, provides medicines for an array of health concerns, including central nervous system disorders, such as schizophrenia and epilepsy; metabolic diseases, such as diabetes; cardiovascular diseases; women’s health; urology; gastrointestinal; and infectious diseases.