Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA? Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer lngelheim. 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 venous thrombosis (DVT)' and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days. It is also indicated to reduce the risk of recurrence of DVT and? PE in patients who have been previously treated. Dabigatran Etexilate Capsules, 150 mg have an estimated market size of USD 410 million for twelve months ending Sep. 2021 according to IQVIA. The company has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval.