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Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol
Represents second complex respiratory therapeutic product approval in Q4 2025 BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals,
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"Represents second complex respiratory therapeutic product approval in Q4 2025\nBRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC. This approval follows the Company’s FDA approval of its beclomethasone dipropionate inhalation aerosol, a generic equivalent of QVAR® (beclomethasone dipropionate inhalation aerosol), further advancing Amneal’s entry into complex inhaled and respiratory drug delivery. Together, these milestones underscore the Company’s momentum in building a differentiated, high-value respiratory portfolio supported by its state-of-the-art manufacturing platform. “Securing two significant inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the tremendous progress our teams have made in a highly complex respiratory category,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “These achievements are the result of years of hard work, engineering excellence, and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.” Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and children 12 years of age and older with reversible obstructive airway disease. The most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. For full prescribing information, see package insert here. According to IQVIA® U.S. annual sales for albuterol sulfate inhalation aerosol for the 12 months ended September 2025 were approximately $1.5 billion. PROAIR® HFA and QVAR® are registered trademarks of Teva Respiratory LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Afforda...