Aurobindo Pharma on Thursday said that it has received tentative approval from the United States Food and Drug Administration (USFDA) to launch an HIV triple combination product for children in low and middle-income countries, including India. The product will be launched under a voluntary license from ViiV Healthcare.

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This would be the first generic product to get the tentative nod from the USFDA for a dispersible tablet formulation of the fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD).

The new drug will be used in treatment of children living with HIV weighing 6 kg to over 25 kg and aged at least 3 months, Aurobindo Pharma said in a filing to the stock exchanges.

The pharma company said that it has a paediatric dolutegravir voluntary license with ViiV Healthcare, which facilitates the development and supply of this product in 123 low and middle-income countries, including India.

Aurobindo Pharma said that its product has already been filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon.

The Hyderabad-based drugmaker informed the bourses that it has capacity to meet the market demand for this product and commercial production will begin in the third quarter of the current financial year (FY24).

The triple combination product has been identified by the WHO as a priority ART option for children living with HIV.

This is one of the fastest approvals for a generic combination product after the clearance of the innovator formulation, with ViiV having secured a USFDA nod in March 2022.

Shares of Aurobindo Pharma were reading 0.28 percent higher at Rs 875.85 apiece on the BSE at 9:28 am. The stock has given multibagger returns to investors so far this year, rising over 100 percent.