Indoco Remedies has received final approval of its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg, to market a generic equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen), from U.S. Food and Drug Administration (USFDA).
Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban Tablets USP, will be manufactured by Indoco Remedies at their manufacturing facility located at Verna Industrial Area, Verna, Goa in India. Rivaroxaban is used for the treatment of venous thromboembolism (VTE).
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
