Amneal FDA Approval Iohexol Injection
Analysis based on 7 articles · First reported Jul 17, 2026 · Last updated Jul 17, 2026
The FDA approval expands Amneal's product portfolio in the contrast agent market, potentially increasing its market share and revenue. The news may positively impact Amneal's stock price as it strengthens its position in the hospital and imaging center supply chain.
Amneal Pharmaceuticals received FDA approval for additional strengths and vial presentations of iohexol injection, a radiographic contrast agent. The newly approved presentations include 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, and 300 mg iodine/mL in a 50 mL vial. These are the first generic versions referencing OMNIPAQUE across these presentations. Amneal plans to launch the products in Q3 2026. The expanded portfolio is expected to address the majority of U.S. iohexol injection market demand, which had annual sales of approximately $706 million according to IQVIA. This approval demonstrates Amneal's leadership in complex injectables and commitment to providing high-quality, reliable medicines.
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