Lupin gets tentative USFDA nod for Apixaban Oral Suspension

New Delhi, Sep 28 (PTI) Pharma major Lupin on Monday said it has received tentative approval from the United States Food and Drug Administration (US FDA) for Apixaban Oral Suspension 1.25 mg/mL.

The drug provides an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets.

In a regulatory filing, Lupin said “It has received tentative approval from the United States Food and Drug Administration (US FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway.”

Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient found in Bristol Myers Squibb’s Eliquis.

“This tentative approval

reflects our 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 our commitment to building a differentiated portfolio,” Lupin CEO Vinita Gupta said.

Upon receiving final approval, the product will be manufactured at Lupin’s Somerset facility in New Jersey, US, the company added. PTI TRB DRR