Pharmaceutical company Strides Shasun today 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 $750 million. The company’s stock was trading 1.90 per cent higher at Rs 806 on BSE.
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