Lupin Limited has secured tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) of Apixaban Oral Suspension (1.25mg/mL). The global pharmaceutical company developed the liquid formulation via the regulatory 505(b)(2) pathway. 

Lupin's Apixaban Oral Suspension 1.25 mg/mL is a liquid version of the blood-thinner apixaban—the same active ingredient found in Eliquis by Bristol Myers Squibb—designed to help adult patients who need blood-clot prevention but struggle to swallow traditional pills. 

“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. 

Once approved, the product will be made at Lupin's Somerset, New Jersey plant, utilizing the company's U.S. manufacturing expertise to ensure high quality and a reliable supply.