Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations
- 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 $706 million.
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.
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Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
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