Indoco Remedies Gets USFDA Nod for Generic Rivaroxaban Tablets

Indoco Remedies Gets USFDA Nod for Generic Rivaroxaban Tablets
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Indoco Remedies Limited has received final USFDA approval for its Abbreviated New Drug Application (ANDA) to market Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. These are bioequivalent and therapeutically equivalent to Janssen Pharmaceuticals’ reference drug, Xarelto Tablets, in the same strengths. The approved product will be manufactured at Indoco’s facility in Verna Industrial Area, Goa. Rivaroxaban is prescribed for the treatment of venous thromboembolism (VTE).

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