East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg, and 300 mg. Aurobindo’s Tenofovir Disoproxil Fumarate Tablets are an AB-rated generic equivalent to the reference listed drug VIREAD®.
Tenofovir Disoproxil Fumarate tablets are indicated for the treatment of HIV-1 infection and for the treatment of chronic hepatitis B.
The product has an estimated market size of $743.4M for the twelve months ending December 2017 according to IMS*.
Tenofovir Disoproxil Fumarate represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 288 final approvals, including 38 tentative approvals, and 17 approved products from Aurolife. There are 107 additional products on file with U.S. FDA.
*IMS National Sales Perspectives: Retail and Non-Retail MAT December 2017