Strides receives US FDA approval for efavirenz, emtricitabine & tenofovir disoproxil fumurate tablets for HIV-1 infection

Strides Pharma Science step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore, has received approval for efavirenz (600mg), emtricitabine (200mg), tenofovir disproxil fumurate (300mg), (EET) tablets from the United States Food & Drug Administration (FDA). This is the first line treatment for HIV-1 infection.
 
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla tablets of Gilead Sciences LLC. The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products.
 
The EET tablet has a market opportunity in the US of ~US$ 7.5 million per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.
 
The PEPFAR approval for Strides qualifies the Company to participate in global donor funded programmes that procure this lifesaving medicine and it is supplied in ~10 countries. As of full year 2022, donor procurement for EET tablets is estimated at a value of ~15 million USD. This product further strengthens the available offerings in HIV treatment from Strides.
 
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.
 
Strides’ EET tablets belong to a class of medication knows as antiretrovirals. This fixed-dose triple-drug combination medication is indicated for treatment of HIV-1 infection in adult patients weighing at least 40kgs.

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