Lupin bags USFDA okay for Desvenlafaxine ER tablets to treat depression
The product will be manufactured at Lupin's facility in Goa, India.
Mumbai: Global pharma major, Lupin Limited, has announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desvenlafaxine Extended-Release Tablets, 25 mg.
The product is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V. Desvenlafaxine is used in the treatment of depression.
The product will be manufactured at Lupin's facility in Goa, India.
Desvenlafaxine Extended-Release Tablets, 25 mg (RLD Pristiq) had estimated annual sales of USD 14 million in the U.S. (IQVIA MAT December 2021).
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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.
