Amneal Secures FDA Approval for Additional Iohexol Injection Presentations, Expanding Hospital Contrast Imaging Portfolio

Amneal Pharmaceuticals has received U.S. FDA approval for additional vial presentations of iohexol injection across 300 mg iodine/mL and 350 mg iodine/mL strengths. The expanded portfolio broadens hospital access to generic contrast media and positions the company to address most U.S. demand for iohexol injection used in diagnostic imaging.

Amneal Pharmaceuticals has received U.S. Food and Drug Administration approval for additional strengths and vial presentations of iohexol injection, including 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, and 300 mg iodine/mL in 50 mL vials. The company expects to commercially launch the newly approved products during the third quarter of 2026.

The approvals build on Amneal’s previously launched iohexol injection 300 mg iodine/mL in 100 mL vials, significantly expanding its injectable contrast media portfolio. With the newly approved presentations, the company expects to cover the majority of U.S. market demand for iohexol injection while offering hospitals and imaging centers greater flexibility in product selection and supply.

Expanded Access to Generic Contrast Media

Iohexol is a nonionic, water-soluble iodinated radiographic contrast agent used to enhance visualization during a wide range of diagnostic imaging procedures. It is approved for intrathecal, intra-arterial, intravenous, oral, rectal, intra-articular, and body cavity imaging in adults and pediatric patients aged two weeks and older.

Contrast agents such as iohexol improve image quality by increasing the visibility of blood vessels, organs, and tissues during computed tomography (CT), angiography, myelography, arthrography, and other radiologic examinations. Reliable access to multiple vial sizes is particularly important for hospitals and imaging centers managing varied patient populations and procedure volumes.

According to Amneal, the newly approved products represent the first generic versions referencing OMNIPAQUE™ across the approved presentations.

Approval Strengthens Amneal’s Institutional Injectables Portfolio

The latest approvals further expand Amneal’s presence in the institutional injectable market, where contrast media remain essential for routine diagnostic imaging. By offering multiple concentrations and vial sizes, the portfolio provides healthcare providers with greater inventory flexibility and may help improve supply resilience.

IQVIA data cited by the company estimate that U.S. annual sales of iohexol injection reached approximately $706 million during the 12 months ending May 2026, highlighting the significant commercial opportunity within the contrast media market.

Arash Dabestani, Senior Vice President of Institutional at Amneal, said the expanded portfolio strengthens the company’s ability to meet the evolving needs of hospitals and imaging centers while reinforcing its position in complex injectable medicines.

Safety Profile

Iohexol injection carries a Boxed Warning against the intrathecal administration of an incorrect iodine concentration, which has been associated with serious and potentially fatal adverse reactions. Reported complications include convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

The most frequently reported adverse reactions vary by route of administration:

• Intrathecal: headache, nausea, back or neck pain, dizziness
• Intra-arterial and intravenous: chest pain, arrhythmias, blurred vision, photomas, altered taste
• Oral: nausea, vomiting, diarrhea, abdominal discomfort
• Body cavity administration: local pain, swelling, and heat sensation

Healthcare professionals should administer the appropriate iodine concentration for each indication and follow the approved prescribing information to minimize the risk of serious complications.

Commercial Launch Planned for Third Quarter of 2026

Amneal plans to launch the newly approved iohexol injection presentations during the third quarter of 2026, further broadening its hospital products portfolio. The expanded range strengthens the company’s position in the U.S. injectable contrast market while increasing the availability of generic imaging agents for healthcare providers performing diagnostic radiology procedures.

Reference

Amneal Pharmaceuticals, Inc. – Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations