Banner Pharmacaps Inc. Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules
Published: Jul 30, 2008
HIGH POINT, N.C.--(BUSINESS WIRE)--Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, today announced that the US Food & Drug Administration (FDA) has granted final approval for the Company’s New Drug Application (NDA) for Valproic Acid Delayed Release soft gelatin capsules in the 125 mg, 250 mg, and 500 mg strengths. This drug is approved for use in the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in multiple seizure types, and for prophylaxis of migraine headaches. It has a similar pharmacokinetic profile to Abbott Laboratories Depakote® delayed release tablets. Banner has partnered with Noven Pharmaceuticals, Inc., who will market and sell this product under the brand name of Stavzor™ through its Noven Therapeutics subsidiary.