Aurobindo Pharma has received final USFDA approval to manufacture and market valganciclovir tablets USP, 450 mg. This product is to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Valcyte of Hoffman-La Roche Inc. The drug is an anti-viral used in the treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome and prevention of CMV disease in kidney, heart or kidney-pancreas transplant patients. It has an estimated market size of US $ 391 million for the 12 months ending February 2016.
Company Profile : Aurobindo Pharma Ltd
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