Laurus Labs receives USFDAs tentative nod for the first Paediatric ARV Oral Dispersible Film drug for AIDS treatment

Laurus Labs receives USFDAs tentative nod for the first Paediatric ARV Oral Dispersible Film drug for AIDS treatment

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

FPJ Web DeskUpdated: Tuesday, May 02, 2023, 03:36 PM IST
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Laurus Labs receives USFDAs tentative nod for the first Paediatric ARV Oral Dispersible Film drug for AIDS treatment | File

Laurus Labs Limited, 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 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."

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