Alembic Pharma gets tentative USFDA nod for generic Rivaroxa
Alembic Pharmaceuticals Ltd on 22nd June said it has received tentative approval from the US health regulator for its generic version of Rivaroxaban tablets used in the treatment of embolism and deep vein thrombosis.

The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) Rivaroxaban tablet is for multiple strengths of 10 mg, 15 mg, and 20 mg, Alembic Pharmaceuticals said in a regulatory filing.

The tablet is the generic of Janssen Pharmaceuticals Inc's reference listed drug product Xarelto.

Rivaroxaban tablets are indicated for multiple conditions, including reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT), and treatment of pulmonary embolism (PE).

The medicine is also used for a reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial six months treatment for DVT and/or PE and prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

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Jun 24, 2020Like1