Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals

Rhea-AI Summary

Amneal (Nasdaq: AMRX) announced U.S. FDA approval of epinephrine injection USP 1 mg/mL in both single-dose (1 mL) and multi-dose (30 mL) vials for hospitals and acute care settings, dated Dec 9, 2025. The approval expands Amneal’s institutional injectables portfolio and targets emergency and perioperative use including treatment of anaphylaxis and septic-shock–related hypotension.

The release notes common adverse reactions and references prescribing information; IQVIA U.S. annual sales for single- and multi-dose epinephrine vials were ~$118 million for the 12 months ended October 2025.

Positive

• FDA approval for epinephrine 1 mg/mL single- and multi-dose vials
• Product portfolio expansion into institutional injectables
• Addressing a ~$118M U.S. annual market for vial presentations

Negative

• Label lists common adverse reactions including cardiovascular effects

Key Figures

Epinephrine dose (single) 1 mg/mL (1 mL) Single-dose vial strength and volume

Epinephrine dose (multi) 1 mg/mL (30 mL) Multi-dose vial strength and volume

IQVIA U.S. sales $118 million Epinephrine injection vials, 12 months ended Oct 2025

Net revenue $784.5 million Q3 2025 net revenue from 10-Q

Net income $2.4 million Q3 2025 net income attributable to Amneal

Diluted EPS $0.01 Q3 2025 diluted earnings per share

Cash & equivalents $201.2 million Balance at September 30, 2025

Long-term debt $2.57 billion Long-term debt, net, at September 30, 2025

Market Reality Check

$12.21 Last Close

Volume Volume 1,781,131 is essentially in line with 20-day average 1,783,696. normal

Technical Price $11.87 is trading above 200-day MA at $8.99, near the -6.39% zone vs 52-week high.

Peers on Argus

AMRX was down 2.55% while key peers PBH, INDV, BHC, HCM, and PRGO were also negative (e.g., INDV -2.97%, BHC -2.57%). However, momentum data did not flag a coordinated sector move, suggesting AMRX trading was more stock-specific than part of a broad sector rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 05	Clinical data update	Positive	+2.4%	Positive interim Phase 4 CREXONT results improving motor symptom metrics in Parkinson’s.
Dec 02	Investor conferences	Neutral	-2.5%	Announcement of participation in two healthcare investor conferences with webcast access.
Dec 02	FDA approval	Positive	-2.5%	FDA approval of albuterol sulfate inhalation aerosol, generic to PROAIR HFA.
Dec 01	FDA approval	Positive	-2.5%	FDA approval of cyclosporine ophthalmic emulsion 0.05%, generic to RESTASIS.
Nov 13	FDA approval	Positive	+1.0%	FDA approval of iohexol injection, first generic of Omnipaque for imaging use.

Pattern Detected

Recent FDA approvals have produced mixed reactions: some approvals (iohexol, sodium oxybate) saw modest gains, while others (albuterol, cyclosporine, bimatoprost) coincided with short-term declines, indicating no consistent upside pattern on approval headlines.

Recent Company History

Over the past few months, Amneal has reported several milestones. On Nov 13, 2025, it gained FDA approval for iohexol injection, followed by ophthalmic and respiratory FDA approvals on Dec 1 and Dec 2, all tied to sizeable IQVIA market opportunities. On Dec 5, positive interim Phase 4 CREXONT data supported its neurology franchise. Conference participation announcements on Dec 2 highlighted investor outreach. Today’s epinephrine approval adds another hospital-focused injectable to this expanding portfolio.

Market Pulse Summary

This announcement adds an FDA-approved epinephrine injectable in both single- and multi-dose vials to Amneal’s hospital portfolio, targeting a U.S. market IQVIA measures at $118 million. It follows multiple 2025 FDA approvals in ophthalmic, respiratory, and imaging products, alongside growing Q3 2025 revenue of $784.5 million. Investors may watch how quickly this product launches into acute-care settings, its share capture versus existing suppliers, and the company’s ability to manage long-term debt of $2.57 billion.

Key Terms

epinephrine medical

"the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials"

Epinephrine, also known as adrenaline, is a fast-acting hormone and medication used to stimulate the heart, open airways and tighten blood vessels during life-threatening emergencies like severe allergic reactions, asthma attacks and cardiac arrest. Investors care because its clinical use and demand drive sales of drug products and delivery devices, influence regulatory approvals and supply chains, and can quickly affect revenue and stock value when shortages, new formulations or policy changes occur.

non-selective alpha and beta adrenergic agonist medical

"Epinephrine is a non-selective alpha and beta adrenergic agonist."

A non-selective alpha and beta adrenergic agonist is a drug that activates multiple types of cellular “switches” used by the nervous system to control heart rate, blood vessel tightness and airway opening. For investors, this matters because such broad activity can produce strong therapeutic effects but also higher risk of side effects and narrower approval or market use, affecting clinical trial outcomes, regulatory review and commercial potential.

anaphylaxis medical

"emergency treatment of allergic reactions (Type 1) including anaphylaxis, which may result"

Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.

mean arterial blood pressure medical

"and to increase mean arterial blood pressure in adult patients with hypotension"

Mean arterial blood pressure (MAP) is the average pressure in a person’s arteries over a full heartbeat and reflects how well blood is pushed through the body to supply organs. Think of it like the average water pressure in a hose that determines whether every faucet gets enough flow; for investors, changes in MAP from a drug, device, or clinical condition are key safety and efficacy signals that can affect regulatory review, market acceptance, and valuation.

septic shock medical

"adult patients with hypotension associated with septic shock."

Septic shock is a life-threatening condition caused by a severe bodily response to infection that leads to dangerously low blood pressure and failing organs. Think of it like a city’s emergency systems collapsing after a major storm: hospitals need intensive care, special drugs and equipment, and longer stays. For investors, its incidence and treatment options matter because they affect demand for drugs, medical devices, hospital resources, trial outcomes, regulatory attention and potential liability costs.

AI-generated analysis. Not financial advice.

• Expands Amneal’s injectables portfolio with an essential medicine used in hospitals for emergency and perioperative care
  
  

BRIDGEWATER, N.J., Dec. 09, 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 epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical therapy utilized by hospitals, emergency departments and other acute care facilities for patient care.

“Epinephrine is one of the most important and widely used emergency medicines in healthcare,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. “By bringing both single- and multi-dose vial presentations to the institutional market, we are helping expand reliable and affordable access for hospitals and clinical providers, while reinforcing Amneal’s commitment to supplying essential medicines that support patient care across the U.S. health system.”

Epinephrine is a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

The most common adverse reactions associated with systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. For prescribing information, see package inserts for single dose vial here and multidose vial here.

According to IQVIA^® U.S. annual sales for epinephrine injection single- and multi-dose vials for the 12 months ended October 2025 were approximately $118 million.

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 9, 2025 regarding epinephrine?

Amneal announced FDA approval of epinephrine injection USP 1 mg/mL in single-dose (1 mL) and multi-dose (30 mL) vials for U.S. hospitals.

How large is the U.S. market for epinephrine vials referenced by Amneal (AMRX)?

Amneal cited IQVIA U.S. annual sales of approximately $118 million for single- and multi-dose epinephrine vials for the 12 months ended October 2025.

Which clinical uses does Amneal’s approved epinephrine 1 mg/mL vial cover?

The 1 mg/mL formulation is indicated for emergency treatment of type 1 allergic reactions including anaphylaxis and to raise mean arterial pressure in adults with hypotension from septic shock.

Will Amneal’s epinephrine vials be available to hospitals and acute care facilities?

Yes, the approval covers single- and multi-dose vial presentations intended for hospitals, emergency departments, and other acute care settings.

What safety information did Amneal highlight for the approved epinephrine (AMRX)?

The label lists common adverse reactions such as anxiety, tremor, palpitations, nausea, headache, and respiratory difficulties, with higher risk in patients with heart disease or hypertension.

Where can clinicians find prescribing details for Amneal’s epinephrine vials (AMRX)?

Prescribing information and package inserts for both the single-dose and multidose vials are provided with the approval announcement.