Cipla, Strides Shasun unit get USFDA approval for HIV drug
New Delhi: Cipla Ltd and a unit of Strides Shasun Ltd have received 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.
The tenofovir disoproxil fumarate tablets, 300 mg, are generic equivalents of Gilead Sciences’ Viread Tablets, 300 mg, the companies said in their separate BSE filings.
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.
Cipla said the product is indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection in adults and paediatric patients 12 years of age and older.
At 11.56am, Cipla shares traded 0.19% down at Rs620.15 on BSE, while Strides Shasun shares rose 2.40% to Rs809.95. The BSE Sensex rose 0.93% to 36,386.12 points.
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