Laurus Labs has received U.S. FDA’s tentative approval for paediatric antiretroviral drug Dolutegravir 5mg and 10mg in oral dispersible film (ODF) dosage form.
The ODF technology will simplify the drug administration in children and help in bringing a significant benefit in compliance of ARV medication in paediatric HIV treatment. “This option will help in strict compliance and adherence in the HIV treatment and benefits caretakers,” founder and CEO Satyanarayana Chava said.
Laurus said it 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 second line treatment. On Tuesday, the company’s shares closed 1.14% higher at Rs.311.15 each on the BSE.