ANI Pharmaceuticals: FDA Accepts Application for Cortrophin Gel Revival

By Colin Kellaher

ANI Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration has accepted its application to reintroduce its Cortrophin Gel treatment for patients with chronic auto-immune disorders.

The Baudette, Minn., pharmaceutical company said the agency set a target action date of Oct. 29 for the potential competitor to Mallinckrodt PLC's Acthar Gel.

The FDA originally approved Cortrophin Gel in 1954, but it was last used in patients in the 1980s. The product has more than 54 indications on its previously approved label, including the treatment of acute exacerbations of multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

ANI, which acquired Cortrophin Gel from Merck in early 2016 and spent more than $100 million to re-establish the product, last year filed for FDA approval to reintroduce it to the U.S. market.

However, the agency turned the application away, citing concerns related to chemistry, manufacturing and controls section. ANI resubmitted the application in June.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 31, 2021 08:53 ET (12:53 GMT)

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