Laurus Labs bags USFDA nod for Paediatric ARV Oral Dispersible Film drug Dolutegravir in HIV/AIDS treatment
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Hyderabad: Laurus Labs Ltd., a R&D driven pharmaceutical & biotech manufacturing company in India, has announced the receipt of the US Food and Drug Administration (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," the company stated.
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 2 nd 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."
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