ANI Announces FDA Acceptance of Supplemental Filing for Cortrophin® Gel 80 U/mL
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
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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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News
- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) had its price target raised by analysts at Raymond James from $47.00 to $48.00. They now have an "outperform" rating on the stock.MarketBeat
- ANI Pharmaceuticals, Inc. (ANIP) CEO Nikhil Lalwani on Q2 2022 Results - Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- ANI Pharmaceuticals Reports Second Quarter 2022 Financial Results; Reports Record Net Revenues and Raises Full-Year 2022 Net Revenue Guidance for Purified Cortrophin® GelBusiness Wire
- ANI Pharmaceuticals Announces the Launch of Acebutolol Hydrochloride Capsules USPBusiness Wire
ANIP
Earnings
- 8/8/22 - Beat
ANIP
Sec Filings
- 8/8/22 - Form 10-Q
- 8/8/22 - Form 8-K
- 8/8/22 - Form 8-K/A
- ANIP's page on the SEC website