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

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Summary

FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride), finalizing a labeling update under NDA 211243.

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Diseases / indications

• Major Depressive Disorder
• Treatment-resistant Depression

Drugs mentioned

• SPRAVATO (ESKETAMINE HYDROCHLORIDE)

Snippet

SUPPL AP for SPRAVATO (ESKETAMINE HYDROCHLORIDE)