MARLBOROUGH, Mass. (AP) — Sepracor Inc. announced that the FDA will take longer than expected to review the company’s application for potential epilepsy drug Stedesa.
The agency was scheduled to make a decision on Jan. 30 but has extended its review by three months to April 30 to review additional study data submitted by Sepracor.
At the FDA’s request, Marlborough, Mass.-based Sepracor submitted additional data on the drug candidate in November