US FDA Approves ANI Pharmaceuticals’ Cortrophin Gel in Prefilled Syringe

ANI Pharmaceuticals announced March 3 that the US FDA had approved a prefilled syringe of its purified Cortrophin gel.

Among its many indications, the treatment targets acute and chronic inflammatory conditions of the eye, including allergic conjunctivitis, diffuse posterior uveitis, and optic neuritis.

The syringe will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options. Cortrophin gel remains available in 5 mL and 1 mL vials.

ANI, of Princeton, New Jersey, acquired Alimera Sciences, maker of Iluvien and Yutiq, in 2024.