FDA Approved: ROFLUMILAST — Original Application (Zydus Pharmaceuticals USA Inc.)

View source ↗

Summary

FDA approves the original ANDA for roflumilast by Zydus Pharmaceuticals USA Inc., enabling a generic version of this COPD therapy. This marks the first generic …

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

Diseases / indications

• Chronic Obstructive Pulmonary Disease

Drugs mentioned

• Roflumilast (roflumilast)

Snippet

ORIG AP for ROFLUMILAST (ROFLUMILAST)