Pharmaceutical company Lupin Limited (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) reported on Monday that it has received tentative US Food and Drug Administration approval for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL under the 505(b)(2) pathway.
The oral liquid formulation contains apixaban, the active ingredient in Bristol Myers Squibb's Eliquis, and is intended to provide an alternative administration option for adults requiring anticoagulation therapy, including patients who have difficulty swallowing tablets.
Subject to final approval, Lupin will manufacture the product at its Somerset, New Jersey facility, supporting US supply through its domestic manufacturing operations.
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