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FDA approves generic equivalent to Viread

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EAST WINDSOR, N.J. — The FDA has granted Aurobindo Pharma Limited final approval for its Abbreviated New Drug Application for Tenofovir Disoproxil Fumarate Tablets, an AB-rated generic equivalent to Viread. The generic tablets are indicated for the treatment of HIV-1 infection and chronic hepatitis B.

Citing data from IMS for the twelve month period ending December 2017, Aurobindo says the product has an estimated market size of $743.4 million.

Tenofovir Disoproxil Fumarate Tablets — 150 mg, 200 mg, 250 mg, and 300 mg — 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.

 


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