Mallinckrodt Announces U.S. FDA Approval of sNDA for Acthar
DUBLIN , March 21, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that an abstract highlighting results from a retrospective analysis evaluating the corticosteroid-sparing effect and reduction of corticosteroid burden of Acthar® Gel (repository corticotropin injection) therapy in patients with advanced sarcoidosis,1 has been selected for a poster presentation at the Academy of Managed Care Pharmacy (AMCP) 2023 Annual Meeting taking place in San Antonio, Texas from March 21-24, 2023.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three and six months ended June 30, 2022.
ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced the launch of Acebutolol Hydrochloride Capsules.
ANI Pharmaceuticals ventured into new territory last November with its first-ever branded product in Purified Cortrophin Gel and is tapping cloud software company Veeva Systems to help it identify best practices for reaching patients and doctors. Under the aegis of a new business unit focused on rare diseases, the Minnesota-based specialty drug company is throwing down the gauntlet against Mallinckrodt Pharmaceuticals’ Acthar Gel, which since 1954 has been the established purified corticotropin injection for refractory symptoms of autoimmune disorders like rheumatoid (RA), multiple sclerosis (MS) and nephrotic syndrome.
BAUDETTE, Minn.--(BUSINESS WIRE)--ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three months ended March 31, 2022.
DUBLIN, March 28, 2022 /PRNewswire/ -- Mallinckrodt plc, (OTCMKTS: MNKKQ) a global biopharmaceutical company, today announced the publication of findings from a retrospective medical records study assessing the real-world utilization and outcomes of Acthar® Gel (repository corticotropin injection) in patients with refractory rheumatoid arthritis (RA) that did not adequately respond to standard-of-care therapies. The results of the study were published in the peer-reviewed journal Drugs in Context.
BAUDETTE, Minn.--(BUSINESS WIRE)--ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced the U.S. commercial availability of Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) 80 U/mL. The commercial launch of Cortrophin Gel, an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, is being led by ANI’s recently established rare disease business unit. Cortrophin Gel is indicated for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome.
ORLANDO, Fla., Dec. 16, 2021 /PRNewswire/ -- Purified Cortrophin™ Gel (repository corticotropin injection USP), an adrenocorticotropic hormone (ACTH)-based injection therapy for those with specific chronic autoimmune and inflammatory conditions, is available through AllianceRx Walgreens Prime. Cortrophin Gel is approved for certain chronic autoimmune disorders, including the treatment of acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome (NS).
BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin