Amneal Secures FDA
Amneal Secures FDA Approval For First Generic Version Of Omnipaque Injection
Amneal Pharmaceuticals, Inc. (AMRX) announced that the U.S. Food and Drug Administration has approved its iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare's Omnipaque injection.
Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and paediatric patients two weeks of age and older.
The FDA approval makes Amneal the first-to-market supplier of this complex injectable. According to IQVIA, U.S. annual sales for iohexol injection for the 12 months ended September 2025 were approximately $652 million.
The product carries a boxed warning. Serious adverse reactions, including risk of death, convulsions, seizures, cerebral haemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema, have been associated with Intrathecal administration of iohexol at the wrong iodine concentration.
Reported adverse reactions vary by route of administration. Intrathecal use may cause headache, nausea, back or neck pain, dizziness. Intra-arterial or venous use may cause chest pain, arrhythmias, blurred vision, photomas, altered taste. Oral use may cause nausea, vomiting, diarrhoea, abdominal discomfort. Body Cavity administration may cause local pain, swelling, and heat sensation.
With FDA approval secured, Amneal plans to launch iohexol injection in the first quarter of 2026, reinforcing its strategy to expand in differentiated, complex injectables and improve access to affordable medicines.
AMRX has traded in the range of $6.68- $12.12 over the past year. The stock closed yesterday's trading at $11.52, down 3.19%.
