Lupin gets USFDA nod for primary biliary cholangitis drug Obeticholic Acid

Published On 2023-03-24 08:30 GMT   |   Update On 2023-03-24 11:43 GMT
Advertisement

Mumbai: Global pharma major, Lupin Limited, has announced that the company has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Obeticholic Acid Tablets, 5 mg and 10 mg.

Obeticholic acid tablets are used for treating primary biliary cholangitis. Primary biliary cholangitis is an autoimmune disease of the liver that destroys bile ducts, which allows bile to stay in the liver and cause damage.

Advertisement

The product is a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc.

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of USD 255 million in the U.S. (IQVIA MAT December 2022).

Read also: Lupin gets USFDA approval for generic equivalent of Rexulti Tablets

Lupin is a 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.

Lupin 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. It invested 8.7% of its revenue in research and development in FY22.

Read also: Lupin alliance partner Caplin Steriles bags USFDA okay for Thiamine Hydrochloride Injectio

Tags:    

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.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News