Lupin Gains US FDA Nod to Launch Generic HIV Drug in the US Market

Pharmaceutical company Lupin announced that it has received authorization from the US health authority to commercialize generic HIV drug in the US market. The Mumbai-based drug manufacturer announced in a statement that it has obtained provisional approval from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for its tablets containing Abacavir, Dolutegravir, and Lamivudine.

The firm's offering is a generic version of Triumeq PD tablets for oral suspension from ViiV Healthcare Company, it stated. The drug company stated that this product would be produced at its Nagpur plant and provided to low- and middle-income nations.

The fixed-dose combination tablet of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg for oral suspension is a single-pill, once-daily regimen, approved for treating HIV-1 infection in children aged 3 months and older who weigh a minimum of 6 kg.

"The provisional endorsement from the USFDA for our Abacavir, Dolutegravir, and Lamivudine Tablets allows us to enhance the health of pediatric patients with HIV-1, thereby greatly augmenting our HIV medication portfolio," stated Ramesh Swaminathan, Executive Director, Global CFO & Head of API Plus SBU at Lupin.

Lupin Limited is a Mumbai-based Indian multinational pharmaceutical firm. They rank among the biggest generic drug manufacturers worldwide in terms of revenue. The company's primary focus areas encompass paediatrics, cardiovascular health, anti-infectives, diabetology, asthma, and anti-tuberculosis.