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Johnson & Johnson has withdrawn an EMEA filing for Comfyde (carisbamate), its investigational drug being developed for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients aged 16 or older.
January 22, 2010
By: Tim Wright
Johnson & Johnson has withdrawn an EMEA filing for Comfyde (carisbamate), its investigational drug being developed for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients aged 16 or older. J&J’s Janssen-Cilag International unit notified the EMEA of its decision to withdraw the marketing authorization application based on the feedback from the EMEA’S Agency’s Committee for Medicinal Products for Human Use. The application was submitted to the agency in August. The company also received a complete response letter from the FDA last August. No further details were provided.
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