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

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.

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

Argus Dec 2 session

-2.52% close to close Open Argus

Details

News Market Reaction – AMRX

On Dec 2, the day this news came out, AMRX closed 2.52% below the previous close.

Data tracked by StockTitan Argus for the Dec 2 session.

Market Context

This announcement detailed U.S. FDA approval of Amneal’s albuterol sulfate inhalation aerosol, a gen...

Analysis

This announcement detailed U.S. FDA approval of Amneal’s albuterol sulfate inhalation aerosol, a generic to PROAIR HFA, targeting bronchospasm in patients aged 12+. It marked the company’s second complex respiratory approval in Q4 2025 and referenced a sizeable U.S. market of $1.5 billion in annual sales. In context with other recent FDA wins and positive clinical data, the news highlighted Amneal’s push into complex, higher-value generics and the importance of execution in respiratory manufacturing and commercialization.

Key Figures

Dose strength: 90 mcg per actuation Indicated age: 12 years and older Adverse reaction threshold: ≥3.0% +1 more

Dose strength

90 mcg per actuation

Albuterol sulfate inhalation aerosol

Indicated age

12 years and older

Bronchospasm treatment/prevention

Adverse reaction threshold

≥3.0%

Most common adverse reactions vs placebo

U.S. annual sales

$1.5 billion

Albuterol sulfate inhalation aerosol, 12 months ended September 2025 (IQVIA)

Historical Context

5 past events · Latest: Dec 09

5 events

1. Dec 09

   FDA approval

   24h Move

   +2.0%

   FDA approval for epinephrine injection single- and multi-dose vials for hospitals.

2. Dec 05

   Clinical data

   24h Move

   +2.4%

   Positive interim Phase 4 CREXONT Parkinson’s data with improved Good On and Off time.

3. Dec 02

   Investor conferences

   24h Move

   -2.5%

   Participation announcements for Piper Sandler and J.P. Morgan healthcare conferences.

4. Dec 02

   FDA approval

   24h Move

   -2.5%

   FDA approval of generic PROAIR HFA albuterol inhalation aerosol in Q4 2025.

5. Dec 01

   FDA approval

   24h Move

   -2.5%

   FDA approval of generic RESTASIS cyclosporine ophthalmic emulsion 0.05%.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

inhalation aerosol, bronchospasm, tachycardia, pharyngitis, +1 more

5 terms

inhalation aerosol medical

"the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation)"

An inhalation aerosol is a medication formulated as tiny liquid or solid particles suspended in gas that a patient breathes into their lungs using a spray device. Investors should care because the delivery method affects how well a drug works, how safe and easy it is to manufacture and regulate, and how widely patients will use it—similar to choosing between a pill and a nasal spray for reaching the right target quickly and reliably.

bronchospasm medical

"indicated for the treatment or prevention of bronchospasm in adults and children"

A bronchospasm is a sudden tightening of the muscles around the airways that narrows breathing passages and causes wheezing, coughing or shortness of breath — like squeezing a flexible straw until air struggles to pass. For investors, bronchospasm is important because it can signal a drug safety issue or side effect that affects clinical trial outcomes, regulatory decisions, product labeling and market acceptance, all of which can influence a company’s financial prospects.

tachycardia medical

"The most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain"

An abnormally fast heart rate — when the heart is racing and may not fill or pump blood efficiently, similar to an engine revving too high. For investors, reports of tachycardia matter because they signal potential safety or effectiveness issues for drugs, devices or treatments, which can affect regulatory approval, product labeling, legal risk and market value.

pharyngitis medical

"adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis"

Pharyngitis is inflammation or infection of the throat (pharynx) that commonly causes sore throat, difficulty swallowing and swollen glands; think of it as a throat cold that makes speaking and eating uncomfortable. Investors watch it because spikes or trends in throat infections can affect healthcare visits, drug and diagnostic sales, workplace absenteeism and insurance costs—similar to how flu patterns can shift demand and revenue in related industries.

rhinitis medical

"tachycardia, pain, dizziness, pharyngitis, and rhinitis."

Rhinitis is inflammation of the nose lining that causes symptoms such as a runny or blocked nose, sneezing, and itching; it can be triggered by allergies, infections or irritants. For investors, rhinitis matters because it drives demand for over‑the‑counter and prescription nasal treatments, seasonal sales swings, and can affect workforce productivity and healthcare costs—much like a traffic jam in the nose that slows normal breathing and daily activity.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

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.