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

BRIDGEWATER, N.J., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and 80 mcg/actuation). The product is the generic equivalent of QVAR^® (beclomethasone dipropionate HFA) inhalation aerosol, a registered trademark of IVAX LLC, a member of the Teva Group.

Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients five years of age and older. It is not indicated for the relief of acute bronchospasm.

This represents Amneal’s first metered-dose inhaler (MDI) inhalation product, marking a significant milestone in the Company’s expansion into complex respiratory therapies.

“Our first metered-dose inhalation product is a landmark achievement for Amneal,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “This milestone reflects years of dedicated work at our state-of-the-art respiratory facility and marks the beginning of an important new therapeutic category for Amneal. With additional inhalation programs advancing, we are well positioned to drive a new growth vector within our Affordable Medicines segment.”

The most common adverse reactions associated with beclomethasone dipropionate HFA inhalation aerosol are headache, pharyngitis; upper respiratory tract infection; rhinitis; increased asthma symptoms; and inhalation route sinusitis. For full prescribing information, please refer to the package insert .

According to IQVIA^® U.S. annual sales for beclomethasone dipropionate HFA inhalation aerosol for the 12 months ended August 2025 were approximately $329 million.

Note: QVAR^® is a registered trademark of IVAX LLC, a member of the Teva Group.

About Amneal

Amneal 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 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit  and follow us on .

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