Lupin gets U.S. FDA tentative nod for Apixaban Oral Suspension

Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its new drug application for Apixaban Oral Suspension 1.25mg/mL.

The approval was obtained through the 505(b)(2), new drug approval, pathway of the regulator. Upon final approval, the product will be manufactured at its Somerset, New Jersey facility, thereby leveraging the company’s U.S.-based manufacturing expertise, Lupin said.

The approved product 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.