Laurus gets tentative USFDA Approval For Paediatric HIV drug

The US Food and Drug Administration (USFDA) granted tentative approval to Laurus Labs Ltd for the world's first oral dispersible film (ODF) Dolutegravir 5mg and 10mg for paediatric anti-retroviral (ARV) treatment of HIV/AIDS. The firm claims that its oral dispersible film technology will make ARV medication administration easier in children. "It will help in bringing a significant benefit in compliance of ARV medication in paediatric HIV treatment," the study stated.

Laurus Labs also announced that it was the first generic company to receive approval for a fixed dose combination of Abacavir-Dolutegravir-Lamivudine 600/50/300 mg, which is used to treat adult HIV patients as second line therapy. According to Laurus Labs founder and CEO Dr Satyanarayana Chava, the company's ODF option will aid in strict compliance and adherence in HIV treatment and will benefit patient carers. Laurus Labs also claimed to be the first generic company to receive approval for a fixed dose combination of Abacavir-Dolutegravir-Lamivudine 600/50/300 mg, which is used to treat adult HIV patients as a second-line therapy.