Amneal Wins FDA Approval for First Generic Omnipaque Injection

Reuters

Nov 14, 2025

Amneal Wins FDA Approval for First Generic Omnipaque Injection

Amneal Pharmaceuticals Inc. has received U.S. FDA approval for its generic iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare's Omnipaque® (iohexol) injection. The company expects to launch the product in the first quarter of 2026. Iohexol is a radiographic contrast agent used in various imaging procedures for adults and pediatric patients. This approval marks a significant milestone for Amneal, reinforcing its position in the market for complex injectables. No other organizations were mentioned as recipients of this regulatory approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amneal Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9575311-en) on November 13, 2025, and is solely responsible for the information contained therein.

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The company expects to launch the product in the first quarter of 2026. Iohexol is a radiographic contrast agent used in various imaging procedures for adults and pediatric patients. This approval marks a significant milestone for Amneal, reinforcing its position in the market for complex injectables. No other organizations were mentioned as recipients of this regulatory approval.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amneal Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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