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FDA approval · 2025-09-23

FDA Approved: DYANAVEL XR — Supplemental Application (NextWave Pharmaceuticals, Inc)

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Summary

The FDA approved a supplemental application for DYANAVEL XR (amphetamine) by NextWave Pharmaceuticals, expanding the approved use under the existing NDA.

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Diseases / indications

Drugs mentioned

  • Dyanavel XR (amphetamine (extended-release))

Snippet

SUPPL AP for DYANAVEL XR (AMPHETAMINE)