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Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol
_↗ investors.amneal.com
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The U.S. Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals, Inc.'s albuterol sulfate inhalation aerosol (90 mcg per actuation), which the company announced is the generic equivalent of Teva Respiratory LLC's PROAIR® HFA.

This significant regulatory achievement follows the company’s recent FDA approval of its beclomethasone dipropionate inhalation aerosol, the generic equivalent of QVAR®, collectively marking a substantial advancement in Amneal’s entry into the complex inhaled and respiratory drug delivery market.

These two inhalation approvals in a single quarter were highlighted by Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines, as evidence of the team's tremendous progress, engineering excellence, and sustained investment in its respiratory platform, positioning the company to deliver meaningful growth and patient impact by building a high-value respiratory portfolio.

The newly approved 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 product enters a valuable market, with U.S. annual sales for albuterol sulfate inhalation aerosol totaling approximately $1.5 billion for the 12 months ended September 2025, according to IQVIA® data. Common adverse reactions reported (≥3.0% and >placebo) include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. Headquartered in Bridgewater, NJ, Amneal Pharmaceuticals operates as a global biopharmaceutical company that manages a diverse portfolio of over 290 pharmaceuticals across three main segments: the Affordable Medicines segment, which is expanding into complex generics and therapeutic areas like the new respiratory products, injectables, and biosimilars; the Specialty segment, which holds a growing portfolio of branded pharmaceuticals focused on central nervous system and endocrine disorders; and the AvKARE segment, which distributes pharmaceuticals and other products primarily to the U.S. federal government, retail, and institutional markets.

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