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ANI Pharmaceuticals Announces FDA Acceptance of Purified Cortrophin® Gel Supplemental New Drug Application for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis, and Nephrotic Syndrome
-- Prescription Drug User Fee Act (“PDUFA”) target action date is October 29, 2021 -- BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (“ANI” or
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"\n-- Prescription Drug User Fee Act (“PDUFA”) target action date is October 29, 2021 --\n\n BAUDETTE, Minn.--(BUSINESS WIRE)--\nANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq:ANIP) today announced that the Company’s supplemental New Drug Application (“sNDA”) for Purified Cortrophin® Gel (“Cortrophin Gel”) has been accepted by the U.S. Food and Drug Administration (“FDA”) for review.\n\n“FDA’s acceptance of our sNDA for Cortrophin Gel marks a significant milestone for ANI. With a PDUFA target action date of October 29, 2021, we are one step closer to bringing a much-needed product to patients and healthcare providers. We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel,” stated Nikhil Lalwani, Chief Executive Officer of ANI Pharmaceuticals.\n\nChris Mutz, Chief Commercial Officer and Head of Rare Disease of ANI Pharmaceuticals, stated, “The availability of a second corticotropin – or ACTH-based – treatment is meaningful for patients struggling with the devastating consequences of chronic auto-immune disorders, including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.”\n\nAbout Purified Cortrophin Gel \n\nPurified Cortrophin Gel (Repository Corticotropin Injection USP) is a purified adrenocorticotropic hormone (ACTH) previously approved in the U.S. for multiple indications including multiple sclerosis (MS), rheumatoid arthritis (RA), and nephrotic syndrome (NS).\n\nAbout ANI\n\nANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.\n\nForward-Looking Statements\n\nTo the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by wo...