ANI Pharmaceuticals, Inc. issued the following announcement on April 29.
ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Cortrophin® Gel. Upon its preliminary review, 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. ANI 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.
Arthur S. Przybyl, ANI's President and CEO commented, "We remain highly confident in our Cortrophin Gel filing and are fully committed to working with the FDA as quickly as possible to address their letter. We believe that the majority of items mentioned have already been addressed in our original March 23rd sNDA filing and that the remaining items can be reasonably addressed. We look forward to clarifying certain aspects of the filing with the agency."
About Cortrophin® Gel
Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/ml) 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. For more information, including the complete list of indications and usages, please see the Full Prescribing Information. An sNDA for Cortrophin® Gel was filed with the FDA on March 23, 2020. The current annual market for Cortrophin® Gel is approximately $950 million and has only one competitor.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.
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