• 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

Amneal Pharmaceuticals, Inc. 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.