Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations
Rhea-AI Summary
Amneal (Nasdaq: AMRX) announced U.S. FDA approval of additional strengths and vial sizes of its iohexol injection: 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vials. Amneal plans to launch these products in the third quarter of 2026.
These new presentations complement the company’s previously approved 300 mg iodine/mL 100 mL vial, creating a broader iohexol portfolio intended to address the majority of U.S. market demand across key presentations and to offer hospitals, imaging centers and healthcare providers more flexibility and supply options. According to Amneal, these are the first generic versions referencing OMNIPAQUE™ across the approved presentations. Iohexol is a radiographic contrast agent for multiple imaging routes in adults and pediatric patients two weeks and older, and carries a boxed warning for serious adverse reactions with intrathecal use at the wrong iodine concentration. IQVIA® estimates U.S. iohexol injection sales at approximately $706 million for the 12 months ended May 2026.
Positive
- FDA approval of additional iohexol strengths and vial sizes
- Iohexol portfolio expected to cover majority of U.S. market demand
- First generic iohexol versions referencing OMNIPAQUE™ across approved presentations
- Access to an estimated U.S. iohexol market of $706 million annual sales
- Planned product launches in Q3 2026 expand Amneal’s complex injectables lineup
Negative
- Iohexol carries a boxed warning for serious adverse reactions, including risk of death with wrong intrathecal concentration
- New iohexol presentations will not launch until third quarter 2026, delaying potential revenue contribution
News Market Reaction – AMRX
In the Jul 17 session, AMRX declined 1.05%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 04 | FDA drug approval | Positive | +5.0% | U.S. FDA approval of romidepsin injection solution with CGT exclusivity. |
| Dec 22 | FDA biosimilar approval | Positive | +0.2% | FDA approval of two denosumab biosimilars referencing Prolia and XGEVA. |
| Dec 09 | FDA drug approval | Positive | +2.0% | FDA approval of epinephrine injection vials for U.S. hospitals. |
| Dec 02 | FDA respiratory approval | Positive | -2.5% | FDA approval of albuterol sulfate inhalation aerosol, generic PROAIR HFA. |
| Dec 01 | FDA ophthalmic approval | Positive | -2.5% | FDA approval of cyclosporine ophthalmic emulsion 0.05%, generic RESTASIS. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
FDA approval headlines for Amneal have produced mixed stock reactions, with three gains and two declines across recent approvals.
Key Terms
intrathecal medical
intra-arterial medical
arachnoiditis medical
rhabdomyolysis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolio
- Portfolio now positioned to address the majority of U.S. iohexol injection market demand across key presentations
- Demonstrates Amneal’s continued leadership in complex injectables and hospital products
BRIDGEWATER, N.J., July 17, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), today announced that it has received U.S. Food and Drug Administration (FDA) approval for additional strengths and vial presentations of iohexol injection, 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, as well as 300 mg iodine/mL in 50 mL vial. Amneal plans to launch these products in the third quarter of 2026.
Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older. The newly approved presentations complement Amneal’s previously approved and launched iohexol injection 300 mg iodine/mL in 100 mL vials.
With approvals now spanning multiple strengths and vial presentations, Amneal expects its iohexol portfolio to address the majority of U.S. market demand for iohexol injection while providing hospitals, imaging centers and healthcare providers with greater flexibility and supply optionality. These approvals represent the first generic versions referencing OMNIPAQUE™ across the approved presentations.
“We are pleased to further expand our injectable contrast portfolio with the approval of additional strengths and vial presentations of iohexol injection,” said Arash Dabestani, Senior Vice President, Institutional. “Amneal now has a comprehensive iohexol portfolio designed to meet the evolving needs of hospitals and imaging centers. These approvals demonstrate our leadership in complex injectables and commitment to delivering high-quality, reliable medicines that support patient care.”
According to IQVIA® U.S. annual sales for iohexol injection for the 12 months ended May 2026 were approximately
Important Safety Information
Boxed Warning: Serious adverse reactions, including risk of death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema, have been associated with Intrathecal administration of iohexol of a wrong iodine concentration.
The most commonly reported adverse reactions based on route of administration are:
- Intrathecal: Headache, nausea, back/neck pain, dizziness
- Intra-arterial / venous: Chest pain, arrhythmias, blurred vision, photomas, altered taste
- Oral: Nausea, vomiting, diarrhea, abdominal discomfort
- Body Cavity: Local pain, swelling, heat sensation
For full prescribing information, see package insert here.
*OMNIPAQUE™ is a registered trademark of GE HealthCare or one of its subsidiaries.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Amneal was founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, and built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States. Our Affordable Medicines segment spans retail generics, injectables, and biosimilars. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For additional information, please visit 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
