USFDA nod to Alembic Pharma stroke and blood clots drug Dabigatran Etexilate
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg.
The 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..
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients.
Atrial fibrillation (AFib) is a type of irregular heartbeat that can lead to blood clots forming in the heart. These clots can travel to the brain and cause a stroke. DVT occurs when blood clots form in the deep veins of the legs or other parts of the body. These clots can break loose and travel to the lungs, causing a potentially life-threatening condition known as pulmonary embolism.
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