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.