Laurus Labs receives FDA’s tentative OK for Dolutegravir
Laurus Labs has received a tentative nod from the Food and Drug Administration for Dolutegravir 5 mg and 10 mg for pediatric ARV treatment.
This pediatric drug administration through oral dispersible film technology developed by Laurus Labs aims to simplify the drug administration in children. It will help in bringing a significant benefit in compliance of ARV medication in the pediatric HIV treatment, Laurus Labs said.
Laurus Labs also was 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.
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Satyanarayana Chava, founder and CEO of Laurus Labs, said, "We are happy to receive the FDA tentative approval for the world's first pediatric ARV drug Dolutegravir 5 mg and 10 mg, Oral Dispersible Film. This option will help in strict compliance and adherence in the HIV treatment and benefits caretakers."