The US Food and Drug Administration has approved additional iohexol injection products for Amneal Pharmaceuticals. The approval includes iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials and iohexol injection 300 mg iodine/mL in a 50 mL vial. Amneal said it plans to launch the products in the third quarter of 2026.

Iohexol is indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adult and pediatric patients aged 2 weeks and older. The approvals add to Amneal's previously approved and launched iohexol injection 300 mg iodine/mL in 100 mL vials.

According to Amneal, it expects its iohexol injection portfolio to address the majority of US market demand. The company also said the approvals represent the first generic versions referencing OMNIPAQUE across the approved presentations.

The prescribing information includes a boxed warning that intrathecal administration of iohexol at the wrong iodine concentration has been associated with serious adverse reactions, including the risk of death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

Intrathecal administration has been associated with headache, nausea, back or neck pain, and dizziness. Intra-arterial or venous administration has been associated with chest pain, arrhythmias, blurred vision, photomas, and altered taste. Oral administration has been associated with nausea, vomiting, diarrhea, and abdominal discomfort, whereas administration into body cavities has been associated with local pain, swelling, and a heat sensation.

Source: Amneal Pharmaceuticals