Hyderabad: Indian pharmaceutical player, Laurus Labs said Sunday it has received tentative approval from the United States Food and Drug Administration for TLD, which is one of a preferred first-line regimen for the treatment of HIV. The approval for Tenofovir/Lamivudine/Dolutegravir (TLD) 300/300/50mg fixed-dose combination (FDC) was given under the US President’s Emergency Plan for AIDS Relief, the company said in a release.
The TLD will be available in the generic form in low and middle-income countries, it said.
The drug will be manufactured from the company’s Unit 2 located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
Commenting on the USFDA approval, Laurus Labs CEO Satyanarayana Chava said, “It is 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 (antiretroviral).
Laurus Labs has also received an Establishment Inspection Report from the USFDA for its Unit 6 located at APSEZ, Atchutapuram, on February 2, it said.
The Company is one of the manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas. Laurus Labs also forayed into Finished Dosages Forms capabilities on the back of existing strengths in APIs.