 "pharma, medicines, drugs")
Alembic Pharmaceuticals Ltd on Monday 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 (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
