Laurus Labs bags USFDA nod for Paediatric ARV Oral Dispersible Film drug Dolutegravir in HIV/AIDS treatment

Written by Ruchika Sharma Published On 2023-05-02T16:24:22+05:30 | Updated On 2 May 2023 4:24 PM IST

Laurus Labs bags USFDA nod for Paediatric ARV Oral Dispersible Film drug Dolutegravir in HIV/AIDS treatment

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."

Founded in 2005, Laurus Labs is a research-driven pharmaceutical and biotechnology company headquartered in Hyderabad. The Company's major focus areas include anti-retroviral, Hepatitis C, and Oncology drugs. It sells its APIs in 56 countries. The company's facilities have been certified and approved by WHO, USFDA, NIP Hungary, PMDA, KFDA and BfArM.

The company also offers integrated CMO and Contract Development and Manufacturing Organization (CDMO) services to Global Innovators from Clinical phase drug development to commercial manufacturing. During FY2023 Laurus generated ₹ 6,041 crore in annual revenue and is listed on the BSE (Bombay Stock Exchange) and the NSE (National Stock Exchange) in India.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751