Generic drugmaker Lupin has secured tentative US FDA approval for its Apixaban Oral Suspension, an anticoagulant alternative for patients unable to swallow tablets.
The approval was granted through the 505(b)(2) new drug pathway, with manufacturing slated for the company's facility in Somerset, New Jersey.
Apixaban serves as the active ingredient in Bristol Myers Squibb’s Eliquis, and this liquid formulation aims to provide a differentiated administration option for adults.