ANI Pharmaceuticals’ supplemental New Drug Application (sNDA) for Purified Cortrophin® Gel has been accepted by the US Food and Drug Administration (FDA) for review, according to a news release from the company.

Chris Mutz, chief commercial officer and head of rare disease at ANI Pharmaceuticals, explained the various uses of the product, stating, “The availability of a second corticotropin – or ACTH-based – treatment is meaningful for patients struggling with the devastating consequences of chronic autoimmune disorders, including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.”

According to the company’s website, ANI Pharmaceuticals’ Purified Cortrophin Gel is a purified adrenocorticotropic hormone (ACTH). ACTH is a hormone secreted by the pituitary gland that causes the adrenal cortex glands to produce cortisol, corticosterone, and aldosterone.

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The gel form of this medication has been approved as a short-term treatment for the acute exacerbation of multiple sclerosis. ACTH gel therapy has also been shown to produce dramatic improvements in patients suffering from rheumatoid arthritis. In addition, studies have shown it is effective in resistant nephrotic syndrome due to membranous nephropathy.

The product has a Prescription Drug User Fee Act target action date of October 29, 2021. Nikhil Lalwani, chief executive officer of ANI Pharmaceuticals, said “we look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel.”


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.; August 31, 2021.