Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2020-05-27

FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

View source ↗

Summary

The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP, updating the drug's approval.

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

Diseases / indications

Drugs mentioned

  • SIRTURO (bedaquiline fumarate)

Snippet

SUPPL AP for SIRTURO (BEDAQUILINE FUMARATE)