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."
Read also: Laurus Lab gets CDSCO panel nod to Manufacture, Market HIV drug Dolutegravir Sodium Oral Film
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.
Read also: Laurus gets CDSCO panel nod to market anti retroviral FDC Tenofovir Alafenamide Fumarate, Lamivudine, Dolutegravir
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