FDA tentatively approves Lupin apixaban oral suspension under 505(b)(2)
Business
Lupin just scored a tentative approval from the US Food and Drug Administration for its new Apixaban Oral Suspension, an oral liquid formulation of apixaban, the active ingredient in Eliquis (apixaban).
This is especially helpful for adults who need anticoagulation therapy but struggle to swallow pills.
The approval came through the FDA's 505(b)(2) pathway.
Lupin will make suspension in Somerset
Once fully approved, Lupin will make this new suspension at its Somerset, New Jersey, facility.
CEO Vinita Gupta says this move shows Lupin's push to offer more patient-friendly options and expand its lineup.
By creating medicines in different forms, Lupin hopes to make treatment easier and improve care for people needing blood thinners, while also growing as a company.