Pharma firm Laurus Labs has received tentative approval from the United States Food and Drug Administration for Tenofovir/Lamivudine/Dolutegravir (TLD) 300/300/50mg fixed dose combination drug.
The product is the preferred first-line regimen for the treatment of people living with HIV.
It will be available in the generic form in low and middle income countries, the company said on Sunday.
The U.S. health regulator had given the tentative approval under the Presidential Emergency Plan for AIDS Relief.
The U.S. Department of Health and Human Services Panel as well as WHO recommend TLD as one of the preferred first line regimen for such people.
Laurus Labs said it expected to commercialise “this important medicine in the access markets.” The product will be manufactured at the company’s Unit 2 located at APSEZ, Atchutapuram, Visakhapatnam.
Company founder and CEO Satyanarayana Chava described it as a significant approval for Laurus Labs, which has forayed into finished dosage forms recently.
“This product would demonstrate the company’s capability to develop fixed dose combinations of ARVs,” he said.
Meanwhile, the company has received an Establishment Inspection Report (EIR) from USFDA for its Unit 6 on February 2.
