Strides Receives Clearance For HIV Drugs From USFDA
Strides Pharma Science on Wednesday said that its step-down wholly owned subsidiary, Strides Pharma Global Singapore, has received approval from the United States Food and Drug Administration (USFDA) for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumurate (300mg), (EET) tablets.
EET tablets belong to a class of medication known as antiretrovirals and this fixed-dose triple-drug combination medication is indicated for treatment of HIV-1 infection in adult patients weighing at least 40kgs. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla Tablets of Gilead Sciences LLC, the company said in a statement.
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 PEPFAR approval for Strides qualifies the company to participate in global donor-funded programs that procure this lifesaving medicine and are supplied in 10 countries. As of the full year 2022, donor procurement for EET Tablets is estimated at a value of USD 15 million.
As per IQVIA, the EET tablet has a market opportunity in the US of USD 7.5Mn. The product will be manufactured at the company’s facility in Bengaluru, the company informed. Strides Pharma at close was trading 2.51 per cent higher at Rs 508.20 at BSE.
