Court Permits FDA to Carve Out Indications, Despite Brand Name’s Orphan Drug Status
A United States District Court has decided generic versions of aripiprazole (Abilify®) may proceed to market despite the brand name drug’s orphan drug status. On April 28, 2015, the FDA approved four generic versions of aripiprazole (Abilify®), which is marketed and sold by Otsuka America Pharmaceutical, Inc. Otsuka sought a temporary restraining order that would…