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ANI Pharmaceuticals Gets FDA OK to Bring Back Cortrophin Gel

By Colin Kellaher

 

ANI Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration has approved the reintroduction of its Cortrophin Gel to treat certain chronic autoimmune disorders.

The Baudette, Minn., pharmaceutical company said the approval includes the treatment of acute exacerbations of multiple sclerosis and rheumatoid arthritis, along with excess urinary protein due to nephrotic syndrome.

ANI said it plans a full-scale commercial launch for the potential competitor to Mallinckrodt PLC's Acthar Gel by early in the first quarter of 2022.

The FDA originally approved Cortrophin Gel in 1954, but it was last used in patients in the 1980s. ANI acquired Cortrophin Gel from Merck & Co. in early 2016 and spent more than $100 million to re-establish the product.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 01, 2021 07:09 ET (11:09 GMT)

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