Strides Shasun arm gets USFDA nod for HIV drug

New Delhi: Pharmaceutical company Strides Shasun said its wholly-owned subsidiary has received approval from the US health regulator for tenofovir disoproxil fumarate tablets, used to treat HIV-1 infections in adults.

In a BSE filing, it said Strides Pharma Global Pte. has received approval from the United States Food and Drug Administration (USFDA) for tenofovir disoproxil fumarate tablets, 300 mg.

The approved product is a generic version of Gilead's Viread tablets, for which patent expired on January 25.

Strides Shasun, which already had tentative approval for the product from the USFDA, said it will launch the product immediately.

Citing IMS sales data, the company said the US market for tenofovir disoproxil fumarate tablets is approximately USD 750 million.