ANI Receives Refusal to File Letter from FDA for Cortrophin® Gel
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
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Source: PR Newswire
BAUDETTE, Minn., April 29, 2020 /PRNewswire/ -- 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 remainin
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- 12/19/25 - Form 4
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