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

Company’s first metered-dose inhalation (MDI) product and establishes a new growth vector for the Affordable Medicines segment

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 here.

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 www.amneal.com and follow us on LinkedIn.

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Certain statements contained herein, regarding matters that are not historical facts, may be Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

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