Lupin gets US FDA tentative nod for Apixaban Oral Suspension

Lupin Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL, developed via the 505(b)(2) pathway. This oral liquid formulation is an alternative administration option for adult patients requiring anticoagulation therapy, particularly those who have difficulty swallowing tablets. The active ingredient is apixaban, the same as in Eliquis® by Bristol Myers Squibb. Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility. This development aligns with Lupin's strategy to focus on differentiated medicines addressing patient needs and expanding its therapeutic portfolio.