Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Valganciclovir Tablets USP, 450 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Valganciclovir Tablets USP, 450 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Valcyte® of Hoffman-LaRoche.
Valganciclovir Tablets 450 mg is an Anti-Viral used in the treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome and the prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk.
The product has an estimated market size of $390.6M for the twelve months ending February 2016 according to IMS*.
Valganciclovir Tablets USP, 450 mg represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 212 final approvals, including 34 tentative approvals and 10 from Aurolife Pharma LLC. There are 121 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT February 2016