Laurus gets tentative USFDA nod for paediatric ARV oral dispersible film drug, Dolutegravir 5mg and 10mg

Laurus Labs announced the receipt of the USFDA tentative approval of their Oral Dispersible Film (ODF) Dolutegravir 5mg and 10mg for paediatric ARV treatment.

A company release informed, “This 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 with ARV medication in 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 second-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.”