Alembic Pharmaceuticals receives USFDA tentative approval for Rivaroxaban Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban Tablets are indicated for i) the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ii) the treatment of deep vein thrombosis (DVT). iii) the treatment of pulmonary embolism (PE). iv) the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE. and v) the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

 

Rivaroxaban Tablets, 1 O mg, 15 mg, and 20 mg have an estimated market size of US$ 6.1 billion for twelve months ending March 2020 according to IQVIA.

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