Alembic obtains FDA’s tentative nod for generic Xarelto

The Food and Drug Administration has given tentative approval to Alembic's rivaroxaban tablets in dosage strengths of 10 mg, 15 mg, and 20 mg.

The product is the generic of Janssen’s Xarelto tablets, 10 mg, 15 mg, and 20 mg.

Rivaroxaban tablets are indicated for the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; the treatment of DVT; the treatment of PE; reduction in the risk of recurrence of DVT and of PE 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.

Rivaroxaban tablets, 10 mg, 15 mg, and 20 mg have a market value of  $6.1 billion for the 12 months ended March 2020, according to IQVIA.