Regulatory Approval Disclosure
Lupin Limited announced 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. The approval was obtained via the 505(b)(2) regulatory pathway.
Product Details
Lupin's Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, which is the active ingredient in Eliquis® (apixaban) of Bristol Myers Squibb. The product provides an alternative administration option for adult patients requiring anticoagulation therapy, specifically addressing the needs of patients who may have difficulty swallowing tablets.
Manufacturing and Supply
Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility. The company will leverage its U.S.-based manufacturing expertise to support high-quality standards and supply reliability.
Management Commentary
Vinita Gupta, CEO of Lupin, stated: "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."
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with presence across India, the U.S., Other Developed Markets, and Emerging Markets. Products are distributed in over 100 markets. The company maintains a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars. Lupin has strong leadership in the U.S. and India across core therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. The company operates 15 state-of-the-art manufacturing facilities and 6 research centers, with a workforce of over 26,000 professionals.
Trademark Notice
Eliquis is a registered trademark of Bristol-Myers Squibb Company.