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Amneal Receives U.S. FDA Approval for Iohexol Injection

By: Amneal Pharmaceuticals LLC via GlobeNewswire

November 13, 2025 at 16:01 PM EST

ⓘ This article is third-party content and does not represent the views of this site. We make no guarantees regarding its accuracy or completeness.

BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque^® (iohexol) injection. Amneal expects to launch the product in the first 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.

“We are very proud to introduce the first-to-market generic version of this critical and widely used injectable contrast agent for patients and healthcare providers,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. “This approval reinforces Amneal’s growing leadership in differentiated, complex injectables and our ongoing commitment to improving access to high-quality, affordable medicines.”

According to IQVIA^® U.S. annual sales for iohexol injection for the 12 months ended September 2025 were approximately $652 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.

Note: OMNIPAQUE is a registered trademark of GE HealthCare or one of its subsidiaries.

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

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