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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.