Alembic Pharma secures USFDA approval for Dabigatran Etexilate Capsules
Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery.;
Vadodara: Alembic Pharmaceuticals Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dabigatran Etexilate Capsules, 110 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals, Inc.
Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery.
Deep Vein Thrombosis (DVT) is a medical condition where a blood clot forms in a deep vein, typically in the legs. This can cause pain, swelling, and redness in the affected area. In some cases, DVT can lead to serious complications if the clot dislodges and travels to the lungs, resulting in a pulmonary embolism.
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