Last Updated on October 6, 2024 by The Health Master
Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), dolutegravir tablets for oral suspension, 5 mg.
USFDA gives this tentative approval to market a generic equivalent of Tivicay PD tablets for oral suspension, 5 mg of ViiV Healthcare Company. This product will be manufactured at Lupin’s Nagpur facility in India.
Dolutegravir tablets for oral suspension (Tivicay PD) had estimated annual sales of USD 1 million in the US (IQVIA MAT March 2023).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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