Alembic Pharma gets tentative US FDA nod for generic Rivaroxaban tablets

Alembic Pharmaceuticals said it has received tentative approval from the US health regulator for its generic version of Rivaroxaban tablets used in treatment of embolism and deep vein thrombosis.

The approval by the US Food & Drug Administration (US FDA) 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’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 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.

Citing IQVIA data, Alembic Pharmaceuticals said Rivaroxaban tablets, 10 mg, 15 mg, and 20 mg have an estimated market size of USD 6.1 billion for the 12 months period ending March 2020.

Alembic now has a total of 124 ANDA approvals (110 final approvals and 14 tentative approvals) from US FDA, it said.