Lupin has received tentative approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) 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.

Vinita Gupta, CEO, Lupin, said, “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.”

Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility, leveraging the company's US-based manufacturing expertise to support high-quality standards, and supply reliability.