FDA Approves New Iohexol Vials

The approval includes additional 300 mg iodine/mL and 350 mg iodine/mL vial presentations.

To announce the FDA approval of additional iohexol injection products by Amneal Pharmaceuticals.

Product Details: 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.
Launch Plans: Amneal plans to launch the products in the third quarter of 2026.
Indications: Iohexol is indicated for various imaging procedures in adult and pediatric patients aged 2 weeks and older.
Market Impact: The approvals add to Amneal's previously approved iohexol injection 300 mg iodine/mL in 100 mL vials and are expected to address the majority of US market demand.
Generic Versions: These approvals represent the first generic versions referencing OMNIPAQUE across the approved presentations.

The prescribing information includes a boxed warning regarding serious adverse reactions associated with incorrect iodine concentrations.
Intrathecal administration risks include death, convulsions, seizures, and other severe complications.
Other administration routes have associated adverse effects such as headache, nausea, and local pain.