Alembic Pharmaceuticals has received tentative approval from the the US Food & Drug Administration (USFDA) for its generic version of Rivaroxaban tablets used in treatment of embolism and deep vein thrombosis.
The approval 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 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.
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 ended March 2020. With this, Alembic now has total of 124 ANDA approvals (110 final approvals and 14 tentative approvals) from USFD.
