Indoco Remedies Receives Final ANDA Approval from USFDA for Rivaroxaban Tablets USP

Indoco Remedies Ltd. has announced the final approval of their Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg, by the US Food and Drug Administration (USFDA). The approved generic equivalent, Rivaroxaban Tablets USP, is 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). The tablets will be manufactured at Indoco's manufacturing facility in Goa, India, and are intended for the treatment of venous thromboembolism (VTE). This approval reflects Indoco's capability to deliver high-quality products and supports their growth aspirations in the US market.