Strides Shasun, Cipla receive FDA approval for HIV drug

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The wholly owned subsidiary of Strides Shasun and Cipla have obtained the final approval from the US Food and Drug Administration Drug (USFDA) for tenofovir disoproxil fumarate tablets, used for the treatment of HIV-1 infections in adults.

This is a generic version of Gilead Sciences' Viread Tablets, 300mg which is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults. The final approval means that product is available for immediate commercialization in the US.

Strides Shasun will be launching the product immediately, as the company already had a tentative approval for the product from the USFDA. As per the reports, the US market for tenofovir disoproxil fumarate tablets is approximately $750 million.