Lupin receives USFDA tentative approval for Apixaban Oral Suspension 1.25 mg/mL

Lupin 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.

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.