FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of July 23, 2020
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.
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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SOURCE ANI Pharmaceuticals, Inc.