Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol

Rhea-AI Summary

Amneal (Nasdaq: AMRX) announced U.S. FDA approval of its albuterol sulfate inhalation aerosol (90 mcg/actuation), the generic equivalent of PROAIR HFA, on December 2, 2025. This approval follows Amneal's recent FDA approval of a beclomethasone dipropionate inhalation aerosol (generic QVAR) and represents the company's second complex respiratory therapeutic approval in Q4 2025.

The company highlighted its respiratory manufacturing platform and positioned these approvals as advancing a differentiated, high‑value respiratory portfolio. IQVIA U.S. annual sales for albuterol sulfate inhalation aerosol were reported at approximately $1.5 billion for the 12 months ended September 2025.

Positive

• FDA approval granted for AMRX albuterol sulfate inhalation aerosol
• Second complex inhalation approval in Q4 2025
• IQVIA U.S. annual market size ~$1.5B (12 months ended Sep 2025)

Negative

• Indication limited to patients 12 years and older
• Common adverse reactions include headache, tachycardia, pain, dizziness, pharyngitis, rhinitis

Insights

Respiratory generics strategist

FDA approval for a branded-equivalent albuterol inhaler and a prior QVAR generic in the same quarter materially advances Amneal's respiratory franchise.

Amneal Pharmaceuticals secured FDA approval for its albuterol sulfate inhalation aerosol (90 mcg per actuation), the generic equivalent of PROAIR® HFA, following a recent approval for a beclomethasone generic. This establishes two complex inhalation approvals in Q4 2025, demonstrating regulatory execution and an operational manufacturing platform able to support complex respiratory products.

The commercial opportunity is explicit: IQVIA U.S. annual sales for this albuterol category were approximately $1.5 billion for the 12 months ended September 2025. The label limits use to patients aged 12 years and older and lists common adverse reactions including headache and tachycardia; these safety details are routine for this class and are already familiar to prescribers and payers.

Key dependencies and near-term milestones are regulatory-to-launch execution and market access steps: ANDA launch timing, interchangeability on formularies, manufacturing scale-up, and distribution agreements. Watch for commercial launch notices and distribution agreements over the next several quarters, which will clarify revenue timing and market share capture.

Represents second complex respiratory therapeutic product approval in Q4 2025

BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR^® HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC.

This approval follows the Company’s FDA approval of its beclomethasone dipropionate inhalation aerosol, a generic equivalent of QVAR® (beclomethasone dipropionate inhalation aerosol), further advancing Amneal’s entry into complex inhaled and respiratory drug delivery. Together, these milestones underscore the Company’s momentum in building a differentiated, high-value respiratory portfolio supported by its state-of-the-art manufacturing platform.

“Securing two significant inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the tremendous progress our teams have made in a highly complex respiratory category,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “These achievements are the result of years of hard work, engineering excellence, and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.”

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 most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. For full prescribing information, see package insert here.

According to IQVIA^® U.S. annual sales for albuterol sulfate inhalation aerosol for the 12 months ended September 2025 were approximately $1.5 billion.

PROAIR^® HFA and QVAR® are registered trademarks of Teva Respiratory LLC.

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 290 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 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 December 2, 2025 about albuterol?

Amneal announced U.S. FDA approval of its albuterol sulfate inhalation aerosol (90 mcg/actuation), a generic equivalent of PROAIR HFA.

What age groups is Amneal's AMRX albuterol inhaler approved for?

It is indicated for treatment or prevention of bronchospasm in adults and children 12 years of age and older.

How large is the U.S. market for albuterol HFA referenced in the AMRX announcement?

IQVIA U.S. annual sales for albuterol sulfate inhalation aerosol were approximately $1.5 billion for the 12 months ended September 2025.

How does the AMRX FDA approval relate to the company's recent approvals in Q4 2025?

The albuterol approval is the company's second complex inhalation approval in Q4 2025, following its beclomethasone dipropionate inhalation aerosol approval.

What are the most common adverse reactions listed for AMRX albuterol inhalation aerosol?

The most common adverse reactions (≥3.0% and greater than placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis.