Strides Shasun receives US FDA approval

The company received the approval for Tenofovir Disoproxil Fumarate Tablets, 300 mg from the United States Food & Drug Administration

Strides Shasun announced that its wholly-owned subsidiary Strides Pharma Global has received approval for Tenofovir Disoproxil Fumarate Tablets, 300 mg from the United States Food & Drug Administration (US FDA). Tenofovir Disoproxil Fumarate tablet is a generic version of Gileads’s Viread Tablet, for which the patent expired on January 25 2018.

Strides is launching the product immediately. The company already had a tentative approval for the product from USFDA for supplying under US President’s Emergency Plan for AIDS Relief (PEPFAR) programme and was able to obtain expedited review of its ANDA application. It is among the first wave of companies launching the product in the US market, after the patent expiry.

According to IMS data, the US market for Tenofovir Disoproxil Fumarate is approximately $750 Million. The product will be manufactured at the company’s Oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US Market.