Aurobindo Pharma receives USFDA approval for Valganciclovir Tablets
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.
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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.
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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.