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ANI Gets Refusal To File Letter For Cortrophin Gel; Seeks Meeting With FDA

ANI Pharmaceuticals Inc. (ANIP) said Wednesday that it received a Refusal to File letter from the U.S. Food and Drug Administration regarding its supplemental new drug application or sNDA for Cortrophin Gel.

The company said it will seek immediate guidance, which potentially includes requesting a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter.

The FDA determined that certain portions of the Chemistry, Manufacturing and Controls section in the sNDA were not sufficiently complete to permit a substantive review.

Purified Cortrophin Gel has 54 indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematous and ulcerative colitis. An sNDA for Cortrophin® Gel was filed with the FDA on March 23, 2020.

In Wednesday pre-market trade, ANIP is trading at $43.65, down $2.25 or 4.90 percent.

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