ANI Pharmaceuticals Announces the Filing of a Prior Approval Supplement for Purified Cortrophin® Gel 80 U/mL
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
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anipharmaceuticals.com/investors_corporate_profile.php
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Source: PR Newswire
BAUDETTE, Minn., March 24, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP), an emerging leader in the specialty pharmaceutical industry, today announced that it has submitted a prior approval supplement (PAS) to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The current annual market for Cortrophin® Gel is approximately $950 million and has only one competitor. Cortrophin® Gel was originally approved by the FDA in 1954 and last used in patients in the 1980s. Cortrophin® Gel has over 54 indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis. ANI acquired the NDA for Cortrophin® Gel from Merck in January of 2016 and has spent over four years and over $100 million to re-establish and validate the commercial corticotropin active pharm
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ANIP
Earnings
- 11/8/24 - Beat
ANIP
Sec Filings
- 12/18/24 - Form 4
- 12/17/24 - Form 144
- 12/16/24 - Form 4
- ANIP's page on the SEC website