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Alembic Pharma bags US FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (US FDA) 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 Ingelheim. 

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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 also reduces 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 $410 million for twelve months ending September 2021 according to IQVIA.

Alembic has received year to date (YTD) 14 approvals (11 final approvals and three tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from US FDA.

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