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H.P. Acthar Gel is a corticotropin injection approved to treat 19 indications, including multiple sclerosis, rheumatoid arthritis, and infantile spasms. The anti-seizure drug often requires daily dosing, and only had a list price of $40 per vial in 2000. Fast forward 20 years later, the dru...
ANI Pharmaceuticals Submit Application for Relaunching Cortrophin Gel ANI Pharmaceuticals Inc. ( ANIP ) announced that it has submitted a Prior Approval Supplement to the FDA. The supplement has been filed with the Endocrinology Division of the regulatory body. The application pertains to ...
BAUDETTE, Minn. , April 14, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that Arthur S. Przybyl will depart as President and Chief Executive Officer on May 10, 2020 . The Board of Directors has retained a nationally recognized executive sea...
The FDA has accepted for review an application from ANI Pharmaceuticals ( ANIP -2.9% ) seeking approval to re-commercialize Purified Cortrophin Gel (repository corticotropin injection USP) 80U/mL. The agency's action date is July 23. More news on: ANI Pharmaceuticals, Inc., Mallinckrod...
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 Cortic...
ANI Pharmaceuticals ( ANIP +1.6% PM) launched their 49th commercial generic drug - Omega-3-Acid Ethyl Esters Capsules, 1 gram. More news on: ANI Pharmaceuticals, Inc., Healthcare stocks news, Read more ...
BAUDETTE, Minn. , April 2, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram. The current annual U.S. market for this product is approximately $110 million , according to IQVIA/IMS...
BAUDETTE, Minn. , March 26, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Polyethylene Glycol 3350, 17g/Packet (PEG-3350). The current annual market for this over the counter (OTC) product is approximately $21 million , according...
ANI Pharmaceuticals ( ANIP +13.1% ) has filed a marketing application with the FDA seeking approval to reintroduce Purified Cortrophin Gel (repository corticotropin injection USP) (80 U/mL) into the U.S. market aimed at taking market share from Mallinckrodt's ( MNK +0.6% ) top seller A...
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-comm...
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PRINCETON, N.J., July 31, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its second quarter 2024 financial results on Tuesday, August 6, 2024, prior to the market open. Nikh...
PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Po...
2024-07-09 17:08:00 ET Stock Traders Daily has produced this trading report using a proprietary method. This methodology seeks to optimize the entry and exit levels to maximize results and limit risk, and it is also applied to Index options, ETFs, and futures for our subscribers. This...