Amneal Pharmaceuticals Receives FDA Approval for First Generic Version of Omnipaque Injection.

Friday, Nov 14, 2025 3:51 am ET1min read

Amneal Pharmaceuticals has received FDA approval for its iohexol injection, the first generic version of GE Healthcare's Omnipaque injection. The product, used for radiographic imaging procedures, carries a boxed warning for potential serious adverse reactions. Annual US sales for iohexol injection were approximately $652 million in the 12 months ended September 2025. Amneal plans to launch the product in Q1 2026.

Amneal Pharmaceuticals Receives FDA Approval for First Generic Version of Omnipaque Injection.

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