Strides Shasun's wholly owned subsidiary Strides Pharma Global Pte. Ltd., has received US FDA approval for tenofvir disoproxil fumarate tablets, 300 mg. This 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 US FDA for supply 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 US$ 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.
Tenofovir disoproooxil fumarate tablets is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. These tablets are also indicated for the treatment of chronic hepatitis B in adults.
Strides shasun, us fda nod, tenofovir disoproxil fumarate tablets
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