FDA pushes back GSK-Valeant drug review
LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.
The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.
The FDA is expected to review the application by Nov. 30.