Lupin gets U.S. FDA tentative nod for Apixaban Oral Suspension
Lupin received tentative approval from the U.S. Food and Drug Administration for its Apixaban Oral Suspension 1.25mg/mL. This approval was granted through the 505(b)(2) new drug application pathway. Final approval will allow production at its Somerset, New Jersey facility, enhancing Lupin's manufacturing capabilities in the U.S.