Aurobindo Pharma has received the US Food & Drug Administration’s (USFDA) tentative approval under the PEPFAR program for the first generic dispersible tablet formulation of the fixed dose combination Abacavir 60mg + Lamivudine 30 mg + Dolutegravir 5 mg (pALD), for the treatment of children living with HIV weighing 6 kg to <25 kg and aged at least 3 months. Aurobindo has a paediatric dolutegravir voluntary licence with ViiV Healthcare, enabling development and supply of this product in 123 Low and Middle-Income Countries (LMIC), including India. This is one of the fastest approvals for a generic combination product following approval of the innovator formulation, with ViiV having secured USFDA approval in March 2022. Aurobindo’s product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon.
The dispersible fixed dose combination of abacavir, dolutegravir and lamivudine is identified by the WHO as a priority ART option for children living with HIV, and this generic approval will help to enable broad and affordable supply in low- and middle-income countries. Aurobindo has capacities in their FDA approved plant to meet the market demand for this product and commercial production will commence in Q3 FY24.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
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