Stavzor Approval History

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.

FDA Approval History for Stavzor

DateArticle
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

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