Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension
Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension |
| [28-September-2026] |
MUMBAI, India and NAPLES, Fla., Sept. 28, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway.
Lupin's Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient in Eliquis® (apixaban) of Bristol Myers Squibb, and provides an alternative administration option for adult patients requiring anticoagulation therapy including those who may have difficulty swallowing tablets. "This tentative approval reflects our continued focus on developing differentiated medicines that address meaningful patient needs. Apixaban oral suspension expands the ways in which this important therapy could be administered, while reinforcing our commitment to building a differentiated portfolio," said Vinita Gupta, CEO, Lupin. Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility, leveraging the company's U.S.-based manufacturing expertise to support high-quality standards, and supply reliability. About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company's business strategy. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin *Safe Harbor Statement
SOURCE Lupin Pharmaceuticals, Inc. | ||
Company Codes: Bloomberg:LPCIN,Bombay:LUPIN.BO,India:LUPIN.NS,RICS:LUPIN.BO |
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