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Amneal Receives FDA Approval for Leuprolide Acetate Injection
Company expects to launch 8 new injectables in 2022 BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\nCompany expects to launch 8 new injectables in 2022\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for leuprolide acetate for injection.\n\nHarsher Singh, SVP for Amneal Biosciences, stated, “We are making tremendous progress expanding our injectables business. This latest new product is another key therapeutic for the institutional market and another complex, high value launch by the team.”\n\nLeuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer. For full prescribing information, see package insert located here.\n\nAccording to IQVIA®, U.S. annual sales for this product for the 12 months ended September 2022 were $81 million.\n\nAbout Amneal\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.\n\nCautionary Statement on Forward-Looking Statements\nCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, strategies, beliefs, expectations or forecasts for the future, including among other things: product research and development; discussions of future operations; expected operating results and financial performance, including pro form...