FDA Tentative Approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

View source ↗

Summary

FDA issued tentative approval for Lupin's generic combination of dapagliflozin and metformin hydrochloride, enabling potential U.S. marketing subject to patent …

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

Diseases / indications

• Type 2 Diabetes Mellitus

Drugs mentioned

• Dapagliflozin and metformin hydrochloride (dapagliflozin and metformin hydrochloride)

Snippet

ORIG TA for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)