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Comfyde FDA Approval Status

FDA Approved: No
Brand name: Comfyde
Generic name: carisbamate
Company: Johnson & Johnson Consumer Inc.
Treatment for: Seizures

Comfyde (carisbamate) is an investigational neuromodulatory agent intended for use as an adjunctive treatment of partial onset seizures.

In August 2009, Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the companies that the New Drug Application (NDA) for Comfyde (carisbamate) had not been approved.

Development timeline for Comfyde

Aug 25, 2009FDA Issues Complete Response Letter for Carisbamate
Oct 24, 2008Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate

Further information

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