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Global pharma major Cipla has received final approval from USFDA to market a generic equivalent of Tenofovir Disoproxil Fumarate 300mg tablets.
Tenofovir Disoproxil Fumarate is an AB-rated generic version of Gilead Sciences' Viread tablets. The drug will be made available for commercial shipment in the USA immediately.
The drug is also covered under U.S. President's Emergency Plan for AIDS Relief (PEPFAR) program and qualified for expedited review by the drug regulator.
At 11:02 hours IST, the stock price was quoting at Rs 804.55, up Rs 13.55, or 1.71 percent on the BSE.
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The two Indian companies are among the first wave of manufacturers launching the product in the USA market.
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.
Pharmaceutical company Strides Shasun today said its wholly-owned subsidiary has received approval from the USA health regulator for tenofovir disoproxil fumarate tablets, used to treat HIV-1 infections in adults.
According to IMS data, the United States market for tenofovir disoproxil fumarate is approximately US$ 750 million.
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