Amneal Receives U.S. FDA Tentative Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol

Core Insights - Amneal Pharmaceuticals has received tentative FDA approval for its first metered-dose inhalation (MDI) product, beclomethasone dipropionate HFA inhalation aerosol, establishing a new growth vector in the Affordable Medicines segment [1][2][3] Product Details - Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma in patients aged five years and older, but not for acute bronchospasm [2] - This product represents Amneal's entry into complex respiratory therapies, marking a significant milestone for the company [2][3] Market Potential - According to IQVIA, annual sales for beclomethasone dipropionate HFA inhalation aerosol were approximately $329 million for the 12 months ending August 2025 [4] Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. [5] - The company is expanding its Affordable Medicines segment across various complex product categories, including injectables and biosimilars [5]