Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment
Drug Approval

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment

  • By IPP Bureau | May 03, 2023

Laurus Labs Ltd., a leading R&D driven pharmaceutical & biotech manufacturing company in India, announces the receipt of the USFDA tentative approval of the World's First Oral Dispersible Film (ODF) Dolutegravir 5mg and 10mg for Pediatric ARV treatment.

This innovative paediatric drug administration through Oral Dispersible Film technology developed by Laurus Labs will simplify the drug administration in children. It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment. Laurus Labs was also the first generic approved company for a fixed dose combination of Abacavir / Dolutegravir / Lamivudine 600/50/300 mg, which is being used to treat adult HIV patients for 2nd line treatment.

Commenting on the USFDA approval, Dr. Satyanarayana Chava, Founder and CEO, Laurus Labs, said, "We are happy to receive the USFDA tentative approval for the World's First Paediatric ARV drug Dolutegravir 5mg and 10mg, Oral Dispersible Film. This option will help in strict compliance and adherence in the HIV treatment and benefits caretakers."

Upcoming E-conference

Other Related stories

Startup

Digitization