Amneal Pharmaceuticals Receives FDA Approval For Additional Iohexol Injection Strengths And Vial Sizes

Amneal Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for additional strengths and vial presentations of iohexol injection, further expanding its portfolio of injectable contrast agents. The newly approved products include iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, as well as iohexol injection 300 mg iodine/mL in a 50 mL vial. The company plans to commercially launch these products during the third quarter of 2026.

Iohexol is a radiographic contrast agent used during a wide range of medical imaging procedures to improve the visibility of internal structures. It is approved for intrathecal, intra-arterial, intravenous, oral, rectal, intra-articular, and body cavity imaging in adults as well as pediatric patients aged two weeks and older. The newly approved presentations expand Amneal's existing iohexol portfolio, which already includes the previously launched 300 mg iodine/mL formulation in 100 mL vials.

With approvals covering multiple strengths and vial sizes, Amneal expects to meet the majority of demand for iohexol injection in the U.S. market. The broader product range is designed to provide hospitals, imaging centers, and healthcare providers with greater flexibility in selecting the most appropriate presentation for different clinical needs while also helping strengthen supply availability. These approvals also represent the first generic versions of the corresponding OMNIPAQUE™ presentations.

Arash Dabestani, Senior Vice President of Institutional at Amneal, said the latest approvals further strengthen the company's injectable contrast portfolio and reinforce its commitment to supporting hospitals and imaging centers with high-quality, reliable products. He noted that the expanded iohexol portfolio reflects Amneal's continued focus on complex injectable medicines and its efforts to address the evolving needs of healthcare providers while improving patient care.

According to IQVIA data, annual U.S. sales of iohexol injection reached approximately $706 million for the 12-month period ending May 2026, highlighting the significant demand for the product. With the planned commercial launch later this year, Amneal is well positioned to expand its presence in the contrast imaging market and provide healthcare providers with a broader range of generic imaging solutions.