Alembic Pharma receives US FDA tentative approval for generic Pradaxa capsules

Rose Nor Rose Nor
Apr 13, 2022 - 22:50
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Alembic Pharma receives US FDA tentative approval for generic Pradaxa capsules

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dabigatran etexilate capsules, 75 mg, 110 mg, and 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer).
 
Dabigatran etexilate capsules, are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients, reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients, prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
 
Dabigatran etexilate capsules, 75 mg, 110 mg, and 150 mg have an estimated market size of US$ 465 million for twelve months ending December 2021 according to IQVIA. Alembic has received a cumulative total of 162 ANDA approvals (139 final approvals and 23 tentative approvals) from US FDA.