FDA Approves AUVELITY Extended-Release Tablet (NDA 215430)

The U.S. Food and Drug Administration has approved AUVELITY, an oral extended‑release tablet that combines bupropion hydrochloride and dextromethorphan hydrobromide, under NDA 215430. AUVELITY is manufactured by Axsome Therapeutics, Inc. and is classified as a prescription human drug. The product is available in two tablet strengths: 105 mg bupropion HCl with either 30 mg or 45 mg dextromethorphan HBr. The FDA’s review included standard and priority submissions. Submission 9 (labeling) received a standard review, while submission 18 (efficacy) was reviewed as priority. Both submissions were approved on April 30, 2026, with associated labeling, medication guide, and efficacy letters publicly available. The approval adds AUVELITY to the market as an oral prescription product, with the FDA providing labeling, medication guide, and efficacy documentation through its access data portal.