Comfyde Approval Status
- FDA approved: No
- Brand name: Comfyde
- Generic name: carisbamate
- Company: Johnson & Johnson
- 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 Status and FDA Approval Process for Comfyde
|Aug 25, 2009||FDA Issues Complete Response Letter for Carisbamate|
|Oct 24, 2008||Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.