The Food and Drug Administration has accepted for review the resubmitted supplemental New Drug Application for Purified Cortrophin® Gel (repository corticotropin injection) for multiple indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.

Purified Cortrophin Gel is a purified adrenocorticotropic hormone. In January 2016, ANI Pharmaceuticals acquired the New Drug Application for Cortrophin Gel from Merck and submitted the supplemental application to the FDA in March 2020. 

In April 2020, the Company received a Refusal to File letter from the FDA stating that certain portions of the Chemistry, Manufacturing and Controls section of the application were not sufficiently complete to permit a substantive review. Since then, the Company has addressed the issues mentioned in the letter.

A Prescription Drug User Fee Act (PDUFA) target date of October 29, 2021 has been set for the application.


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Chris Mutz, Chief Commercial Officer and Head of Rare Disease of ANI Pharmaceuticals, stated, “The availability of a second corticotropin – or [adrenocorticotropic hormone]-based– treatment is meaningful for patients struggling with the devastating consequences of chronic autoimmune disorders.”

References

  1. ANI Pharmaceuticals announces FDA acceptance of Purified Cortrophin® Gel supplemental New Drug Application for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome. News release. ANI Pharmaceuticals, Inc. Accessed August 31, 2021. https://www.businesswire.com/news/home/20210831005322/en/ANI-Pharmaceuticals-Announces-FDA-Acceptance-of-Purified-Cortrophin%C2%AE-Gel-Supplemental-New-Drug-Application-for-Multiple-Indications-Including-Multiple-Sclerosis-Rheumatoid-Arthritis-and-Nephrotic-Syndrome
  2. ANI receives Refusal to File letter from FDA for Cortrophin® Gel. News release. ANI Pharmaceuticals, Inc. Accessed August 31, 2021. https://www.prnewswire.com/news-releases/ani-receives-refusal-to-file-letter-from-fda-for-cortrophin-gel-301048877.html.