Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) 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. Valganciclovir Tablets 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.
The approved product has an estimated market size of US$ 391 million for the twelve months ending February 2016 according to IMS. This is the 69th ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 251 ANDA approvals (215 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.