Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2026-02-02

FDA Approved: FIDAXOMICIN — Original Application (Apotex Corp.)

View source ↗

Summary

FDA approved Apotex Corp.'s original ANDA for fidaxomicin (fidaxomicin) as a generic treatment for Clostridioides difficile infection.

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

Diseases / indications

Drugs mentioned

  • Fidaxomicin (fidaxomicin)

Snippet

ORIG AP for FIDAXOMICIN (FIDAXOMICIN)