Catalyst Wire Dossier Catalyst Wire Dossier
FDA label_change · 2019-01-31

FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

View source ↗

Summary

The FDA approved a supplemental application for Prezista (darunavir) filed by Janssen Products LP. The approval pertains to changes to the product labeling.

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

Diseases / indications

Drugs mentioned

  • PREZISTA (darunavir)

Snippet

SUPPL AP for PREZISTA (DARUNAVIR)