FDA Approves ACTHAR Injectable (NDA007504)

The U.S. Food and Drug Administration has recorded approval under application number NDA007504 for the ACTHAR injectable products. Both formulations—25 UNITS per vial and 40 UNITS per vial—are listed as discontinued and are not reference drugs. The sponsor for this New Drug Application is Sanofi Aventis US. The original submission (submission 1) was classified as a Type 1 New Molecular Entity and received priority review on July 3 1950. Since then, the FDA has issued a series of priority labeling supplements (submissions 9, 10, 13‑16, 18‑20, 14) spanning from 1975 to 1992, each with an “AP” (approved) status. These labeling updates reflect ongoing regulatory activity for ACTHAR despite its discontinued marketing status.