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ANI Pharmaceuticals Re-files SNDA For Cortrophin Gel

ANI Pharmaceuticals, Inc. (ANIP) on Tuesday said it has re-filed its supplemental new drug application (sNDA) for Cortrophin Gel with the U.S. Food and Drug Administration

In April 2020, the FDA had rejected the company's sNDA for Cortrophin Gel citing certain portions of the Chemistry, Manufacturing and Controls section in the sNDA were not sufficiently complete.

Purified Cortrophin Gel is approved for a variety of indications including multiple sclerosis, rheumatoid arthritis, systemic lupus among others.

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