Alembic Pharma gains 6% on USFDA nod for new drug

Alembic Pharmaceuticals rose 6% to Rs 545 on BSE in intra-day trade after the company said that it has received US Food & Drug Administration (USFDA) tentative approval for its abbreviated new drug application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. “The tentative approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim,” Alembic Pharma said in press release. Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep vanous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, the company said. It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated, it added. Future & Option Trading Tips