Lupin Secures FDA Tentative Approval for Liquid Apixaban

The drug serves as an alternative to Bristol Myers Squibb’s Eliquis, specifically targeting adults who require anticoagulation therapy but face physical barriers to tablet consumption. By securing this tentative clearance, Mumbai-based Lupin moves closer to manufacturing the medication at its Somerset, New Jersey facility, aiming to bolster supply reliability for the U.S. market.

CEO Vinita Gupta noted that the development aligns with the company’s focus on differentiated medicines designed to address specific patient needs. While the approval remains tentative, the company intends to leverage its existing manufacturing infrastructure to meet quality standards once the final green light is issued. This move reinforces Lupin’s long-standing presence in the cardiovascular therapeutic space, where it already manages a diverse range of generics and specialty medicines across more than 100 global markets.