Lupin Ltd has received tentative approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Apixaban Oral Suspension 1.25 mg/mL through the 505(b)(2) regulatory pathway.
The product is a liquid formulation of apixaban, the active ingredient in Bristol Myers Squibb’s Eliquis, and is designed to provide an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets.
Differentiated formulation
Lupin said the Apixaban Oral Suspension is part of its strategy to develop differentiated medicines addressing specific patient needs.
Lupin Ltd, CEO Vinita Gupta, said the tentative approval reflects the company’s 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 the company’s commitment to building a differentiated portfolio,” Gupta said
The 1.25 mg/mL oral suspension could offer an alternative dosage form for patients for whom swallowing conventional tablets presents a challenge, subject to final regulatory approval and prescribing requirements.
US manufacturing
Upon final approval, Lupin plans to manufacture the product at its Somerset, New Jersey facility.
The company said the US-based manufacturing site will leverage its local manufacturing capabilities to support product quality and supply reliability.
The tentative approval through the 505(b)(2) pathway also adds another differentiated product to Lupin’s US pharmaceutical portfolio. Unlike a conventional abbreviated new drug application, the 505(b)(2) pathway can be used for certain products that rely partly on existing information while incorporating changes or new characteristics.
Lupin said the product remains subject to final approval before commercial launch in the US.