Lupin Receives USFDA Approval for Its Generic Tablet, Opening New Treatment Options


Lupin Limited, a global pharmaceutical major, has achieved another milestone with the approval of its tablet by the United States Food and Drug Administration (USFDA)[^1^]. The regulatory authority has granted tentative approval for Lupin’s tablet, marking an important step in expanding treatment options for patients.

The tablet in question is the generic equivalent of Ocaliva® Tablets, developed by Intercept Pharmaceuticals, Inc. Lupin’s generic tablet, named Obeticholic Acid Tablets, is available in 5 mg and 10 mg strengths. This approval provides Lupin the opportunity to enter the market and offer an affordable alternative to the branded medication.

Obeticholic Acid Tablets have shown promising potential in treating certain medical conditions.

The tentative approval from the USFDA highlights the rigorous testing and compliance standards met by Lupin, ensuring the quality and efficacy of the medication.

The approval comes as a significant achievement for Lupin, further solidifying its position as an innovation-led pharmaceutical company. With a wide range of branded and generic formulations, Lupin has a strong presence in various therapeutic segments, including cardiovascular, anti-diabetic, respiratory, anti-infective, gastro-intestinal, central nervous system, and women’s health. Lupin is recognized as the third-largest pharmaceutical company in the U.S. in terms of prescriptions and continues to invest a substantial portion of its revenue in research and development.

This recent approval adds to Lupin’s portfolio of successful regulatory clearances. It demonstrates the company’s commitment to providing affordable and accessible healthcare solutions to patients worldwide. The availability of Lupin’s generic tablet will not only expand treatment options but also contribute to reducing healthcare costs.

As Lupin continues to make advancements in the pharmaceutical industry, the company remains focused on innovation, research, and development. With its global presence and dedication to improving patient outcomes, Lupin is poised to make a significant impact in the healthcare landscape.