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Amneal Launches Generic Dexamethasone Following ANDA Approval by FDA
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it is launching
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":" BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it is launching dexamethasone, 4mg and 6 mg, following Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA).\n\nDexamethasone, the generic version of Decadron®, is a well-established anti-inflammatory glucocorticoid steroid used to treat several medical conditions, including respiratory complications associated with COVID-19.\n\n“Today’s approval and launch of dexamethasone reflects the continued execution of our innovation agenda. Expanding access to essential therapies, particularly in the treatment of COVID-19, is core to our mission at Amneal and we are pleased to play our part,” said Chirag and Chintu Patel, Co-Chief Executive Officers.\n\nAccording to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for 4 mg and 6 mg dexamethasone tablets for the 12 months ended August 2021 were approximately $63 million.\n\nDexamethasone tablets can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Elevated blood pressure, sodium and water retention, and increased excretion of potassium, have also been reported.\n\nMild to severe infection with exacerbation may occur with the use of dexamethasone tablets alone or in combination with other immunosuppressive agents. Dexamethasone is contraindicated in patients hypersensitive to any components of this product.\n\nSee Package Insert (PI) for full prescribing information including Safety Information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ac71f888-c83a-46a5-921c-1ebdf6cfadc1&type=display\n\nAbout Amneal\n\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug 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\nAmneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company als...