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Aurobindo Pharma gets US FDA nod for valganciclovir tabs

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Valganciclovir tablets is an anti-viral used in the treatment of Cytomegalovirus (CMV) retinitis

Aurobindo Pharma received final approval from the US Food & Drug Administration (US FDA) 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. According to IMS, the approved product has an estimated market size of US $ 391 million for the 12 months ending February 2016.

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 US FDA.

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