Amneal Receives U.S. FDA Tentative Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol
Rhea-AI Summary
Amneal (NYSE:AMRX) announced on October 29, 2025 that the U.S. Food and Drug Administration has provided tentative approval for its ANDA for beclomethasone dipropionate HFA inhalation aerosol in 40 mcg and 80 mcg strengths.
The product is the generic equivalent of QVAR and is indicated as maintenance prophylactic therapy for asthma in patients five years and older (not for acute bronchospasm). This is Amneal’s first metered‑dose inhaler (MDI), marking an expansion into complex respiratory therapies. IQVIA U.S. annual sales for the branded product were approximately $329 million for the 12 months ended August 2025.
Positive
- First MDI product for Amneal, expanding product portfolio
- Entry into complex respiratory therapies opens new growth vector
- Branded market size: $329M U.S. annual sales (12 months ended Aug 2025)
Negative
- Tentative FDA approval (not final marketing approval)
- Product not indicated for relief of acute bronchospasm
- Common adverse reactions include headache and upper respiratory infection
News Market Reaction
On the day this news was published, AMRX gained 1.36%, reflecting a mild positive market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $44M to the company's valuation, bringing the market cap to $3.28B at that time.
Data tracked by StockTitan Argus on the day of publication.
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
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.
Cautionary Statement on Forward-Looking Statements
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.
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
FAQ
What did Amneal (AMRX) announce on October 29, 2025 about beclomethasone HFA?
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