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Strides Shasun receives USFDA's nod for Tenofovir Disoproxil Fumarate Tablets

29 Jan 2018 Evaluate

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

The company 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) program 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 Bangalore and will be marketed by Strides Pharma Inc. in the US Market.

Tenofovir Disoproxil Fumarate Tablets is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Tenofovir Disoproxil Fumarate Tablets is also indicated for the treatment of chronic hepatitis B in adults.

Strides Shasun (formerly known as Strides Arcolab) is engaged in manufacturing, sale and export of pharmaceutical products. It offers general tablets, hard gelatin and soft gelatin capsules, sachets, potent drugs and semi-solids.

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