Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Voriconazole Tablets, 50 mg and 200 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Voriconazole Tablets, 50 mg and 200 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), VFEND® Tablets, 50 mg and 200 mg, of PF Prism C.V. (Prism).
Voriconazole Tablets, 50 mg and 200 mg is indicated for use in patients 12 years of age and older in the treatment of fungal infections.
The product has an estimated market size of $102.7M for the twelve months ending November 2015 according to IMS*.
Voriconazole Tablets, 50 mg and 200 mg represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 202 final approvals, including 29 tentative approvals and 10 from Aurolife Pharma LLC. There are 122 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT November 2015