Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-04-29

FDA Approved: ZELVYSIA — Original Application (Aucta Pharmaceuticals, Inc.)

View source ↗

Summary

The FDA approved Zelvysia (sapropterin dihydrochloride) via an original Abbreviated New Drug Application from Aucta Pharmaceuticals, Inc. for the treatment of p…

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

Diseases / indications

Drugs mentioned

  • ZELVYSIA (Sapropterin dihydrochloride)

Snippet

ORIG AP for ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE)