iohexol injection
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Amneal Receives U.S. FDA Approval for Iohexol Injection
Globenewswire· 2025-11-13 21:01
Core Insights - Amneal Pharmaceuticals has received FDA approval for its iohexol injection, marking it as the first generic version of GE Healthcare's Omnipaque, with an expected launch in Q1 2026 [1][3] - The iohexol injection is a radiographic contrast agent used for various imaging procedures in both adults and pediatric patients aged two weeks and older [2] - The annual sales for iohexol injection in the U.S. for the 12 months ending September 2025 were approximately $652 million, indicating a significant market opportunity for Amneal [3] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 290 pharmaceuticals, primarily in the U.S. market [6] - The company is expanding its Affordable Medicines segment across complex product categories, including injectables and biosimilars, while also growing its Specialty segment focused on central nervous system and endocrine disorders [6]