Alembic Pharma Gains USFDA Approval for Generic Stroke and Clot Reducing Capsules

Alembic Pharmaceuticals Ltd has received final USFDA approval for its generic Dabigatran Etexilate capsules, in strengths of 75 mg and 150 mg, intended to reduce the risk of stroke and blood clots in adults with a specific medical condition. Additionally, tentative approval was granted for the 110 mg dosage.

Alembic Pharmaceuticals Ltd secured final approval from the US Food & Drug Administration (USFDA) on Tuesday for its generic Dabigatran Etexilate capsules, available in 75 mg and 150 mg doses. These capsules aim to lessen the risk of stroke and blood clots in adults suffering from a particular medical condition.

The 110 mg dosage form of Dabigatran Etexilate capsules also received tentative approval from the USFDA, as per the company's statement. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the Reference Listed Drug product (RLD), Pradaxa Capsules, produced by Boehringer Ingelheim Pharmaceuticals, Inc., in the same dosages.

The capsules are designated for reducing the risk of stroke and systemic embolism in adults with atrial fibrillation not stemming from a heart valve problem. They are also used for treating and lowering the recurrence risk of deep venous thrombosis and pulmonary embolism.

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