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Amneal Announces the Approval and Launch of Generic Carafate®
BRIDGEWATER, NJ.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received final U.S. Food and Drug Administration
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":" BRIDGEWATER, NJ.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received final U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Carafate® (sucralfate) Oral Suspension, 1 g/10 ml. Amneal has immediately initiated commercialization activities.\n\n\n“We are proud to announce our approval for the first generic Sucralfate Oral Suspension, one of the 15 complex products we expect to launch over an 18 to 24-month period,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Developing the first generic version of a drug involves significant technical complexity, and this approval underscores Amneal’s ability to set itself apart. We remain excited about the additional, high-value opportunities in our pipeline and are committed to delivering affordable generic products to our patients. With a diverse and strong generics and specialty portfolio, along with our commitment to operational excellence, we expect to return to growth and drive meaningful value for stakeholders in 2020 and beyond.”\n\n\nAccording to IQVIA™, U.S market annual sales for the 12 months ended October 31, 2019, for sucralfate oral suspension was estimated to be approximately $285 million.\n\n\nAbout Amneal\n\n\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.\n\n\nAmneal has an extensive portfolio of more than 300 generic medicines and is expanding its portfolio to include complex dosage forms in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system disorders, endocrinology and parasitic infections. For more information, visit www.amneal.com.\n\n\nSafe Harbor Statement\n\n\nCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regard...