ANI Announces FDA Acceptance of Supplemental Filing for Cortrophin® Gel 80 U/mL
ANI Pharmaceuticals, Inc. (ANIP)
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Source: PR Newswire
BAUDETTE, Minn., April 13, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that the U.S. Food & Drug Administration ("FDA") has accepted its supplemental new drug application ("sNDA") for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The FDA set a PDUFA goal date of July 23, 2020.Arthur Przybyl, ANI's President and CEO commented, "The acceptance of our filing with a confirmed four-month goal date is an important milestone in our re-commercialization effort for this drug. Notably, in the letter, FDA acknowledged our stated objective of lowering the cost of this drug. We are prepared to immediately launch Cortrophin® Gel in July if FDA approves our filing at that time. We look forward to introducing a new treatment option for patients and physicians and much needed competition into the market."The current annual market for repository corticotropin injection 80 U/ml is $950 million and has only one competitor. Abou
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