Lupin receives tentative U.S. FDA approval

Lupin receives tentative U.S. FDA approval 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 1.25 mg/mL. Key highlights: The product is an oral liquid formulation of apixaban, an anticoagulant. It offers an alternative for adult patients requiring anticoagulation therapy who may have difficulty swallowing tablets. Upon final approval, the product will be manufactured at Lupin’s facility in Somerset, New Jersey, USA. Impact: Positive. The tentative FDA approval expands Lupin’s portfolio of differentiated medicines and offers an alternative administration option for patients. Final approval remains pending.