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Stavzor FDA Approval History

FDA Approved: Yes (Discontinued) (First approved July 29, 2008)
Brand name: Stavzor
Generic name: valproic acid
Dosage form: Capsules
Company: Bionpharma Inc.
Treatment for: Bipolar Disorder, Seizures, Epilepsy, Migraine Prevention

Marketing Status: Discontinued

Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

Development timeline for Stavzor

Jul 30, 2008Approval Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches
Dec 27, 2007Noven Announces FDA Tentative Approval of Stavzor Valproic Acid Delayed Release Capsules
Oct 24, 2007FDA Issues Approvable Letter for Stavzor Delayed Release Valproic Acid Capsules

Further information

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