India, Aug. 13 -- Indoco Remedies Ltd has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market Rivaroxaban Tablets USP in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. The product is the generic equivalent of Xarelto Tablets, developed by Janssen Pharmaceuticals, Inc.
The approved tablets are bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco's facility in Verna Industrial Area, Goa. Rivaroxaban is prescribed for the treatment of venous thromboembolism (VTE).
Commenting on the milestone, Managing Director Aditi Panandikar said the approval not only highlights Indoco Remedies' ability to deliver high-quality prod...