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Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol
Globenewswire· 2025-12-02 13:00
Core Insights - Amneal Pharmaceuticals has received FDA approval for its albuterol sulfate inhalation aerosol, marking the second complex respiratory therapeutic product approval in Q4 2025 [1] - This approval follows the earlier FDA approval of beclomethasone dipropionate inhalation aerosol, indicating Amneal's strategic advancement in the complex inhaled and respiratory drug delivery market [2] Company Developments - The recent approvals highlight significant progress in Amneal's respiratory product offerings, showcasing the company's commitment to engineering excellence and investment in its respiratory platform [3] - Albuterol sulfate inhalation aerosol is indicated for treating or preventing bronchospasm in adults and children aged 12 and older with reversible obstructive airway disease [3] Market Context - The annual sales for albuterol sulfate inhalation aerosol in the U.S. for the 12 months ending September 2025 were approximately $1.5 billion, indicating a substantial market opportunity for Amneal [4]