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

View source ↗

Summary

FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride), resulting in labeling changes for the product.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Major Depressive Disorder
• Major Depressive Disorder with Acute Suicidal Ideation or Behavior
• Treatment-resistant Depression

Drugs mentioned

• SPRAVATO (ESKETAMINE HYDROCHLORIDE)

Snippet

SUPPL AP for SPRAVATO (ESKETAMINE HYDROCHLORIDE)