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FDA approval · 2025-03-24

FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

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Summary

FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride) under NDA 211243, updating the product's indications.

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Diseases / indications

Drugs mentioned

  • SPRAVATO (ESKETAMINE HYDROCHLORIDE)

Snippet

SUPPL AP for SPRAVATO (ESKETAMINE HYDROCHLORIDE)