dabigatran etexilate mesylate oral suspension (WD-1602) / Shanghai Fudan-Zhangjiang, China NT Pharma - LARVOL DELTA

Alembic Pharma receives USFDA approval for Dabigatran Etexilate Capsules (Business Standard) - "Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery."

ANDA • Cardiovascular