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Alembic receives tentative approval from US FDA for blood clot prevention tablet Rivaroxaban

Home grown pharma company Alembic on Monday announced that it 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. 

In a press release filed with exchanges, Alembic Pharmaceuticals said, 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 is a blood thinner which is predominantly used for reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), 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 the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. 

The company said Rivaroxaban Tablets, 10 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. 

Alembic now has a total of 124 ANDA approvals (110 final approvals and 14 tentative approvals) from USFDA.

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