Amneal Secures FDA Approval for First Generic Iohexol Injection A Generic Radiographic Contrast Agent Ahead Of 2026 Launch; Challenging Omnipaque® Market

Amneal Pharmaceuticals announced that the U.S. FDA has approved its iohexol injection (300 mg Iodine/mL), marking the first generic alternative to GE Healthcare’s Omnipaque®. The company plans to introduce this product in the first quarter of 2026, expanding its offerings in the imaging and contrast agent market.

“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.”

Iohexol is a widely used radiographic contrast agent administered through multiple routes—including intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and various body cavity procedures—for both adults and pediatric patients aged two weeks and older. The authorization arrives in a market valued at $652 million in U.S. sales over the 12 months ending September 2025, according to IQVIA.

Amneal also highlighted important safety considerations, noting that intrathecal use with incorrect iodine concentrations has been associated with severe and potentially fatal reactions. These include seizures, convulsions, paralysis, cerebral hemorrhage, acute renal failure, cardiac arrest, and other critical events. Proper dosing and concentration are essential to ensure safe clinical use of the product.