Alembic Pharma secures USFDA approval for Dabigatran Etexilate Capsules

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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In Pulmonary Embolism (PE), a blood clot, often originating from the deep veins of the legs (deep vein thrombosis), travels to the lungs and blocks a pulmonary artery. This blockage can impair blood flow to lung tissue, causing symptoms such as sudden shortness of breath, chest pain, and coughing. 

Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA for its ANDA for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg.

Read also: USFDA nod to Alembic Pharma stroke and blood clots drug Dabigatran Etexilate

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

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