AMRX

FDA Approves Amneal's Generic Version Of GE's Omnipaque; Launch Expected In Q1 2026

(RTTNews) - Amneal Pharmaceuticals Inc. (AMRX) announced that the U.S. Food and Drug Administration has approved its iohexol injection (300 mg Iodine/mL), marking the first generic version of GE Healthcare's Omnipaque (iohexol) injection. The company plans to launch the product in the first quarter of 2026.

Iohexol is a radiographic contrast agent used in a wide range of imaging procedures, including intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity applications. It is indicated for use in both adults and pediatric patients aged two weeks and older.

According to IQVIA U.S. annual sales for iohexol injection for the 12 months ended September 2025 were approximately $652 million.

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