Lupin Dolutegravir Tablets for Oral Suspension gets tentative USFDA nod for HIV/AIDS

Published On 2023-07-04 12:08 GMT   |   Update On 2023-07-04 12:08 GMT

Mumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg.The product is a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company.Dolutegravir is...

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Mumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg.

The product is a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company.

Dolutegravir is an antiretroviral medication used, together with other medications, for the treatment of HIV/AIDS.

This product will be manufactured at Lupin’s Nagpur facility in India. Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD ) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023).

Read also: Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray

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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
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