Strides Pharma bags USFDA nod for Efavirenz, Emtricitabine, Tenofovir Disproxil Fumurate tablets for HIV
Bangalore: Strides Pharma Science Limited has announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumurate (300mg), (EET) tablets from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla Tablets of Gilead Sciences LLC.
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 atleast 40kgs.
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$ 7.5Mn 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 programs 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 ~15mn USD.
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.
