Amneal gains FDA approval for four iohexol presentations

• Amneal received FDA approval for four additional iohexol injection presentations, including three 350 mg iodine/mL vial sizes.
• Amneal shares were up 4.88% at $18.04 following the announcement.
• The company plans to launch the products in Q3 2026, expanding its generic contrast-agent portfolio.

Amneal Pharmaceuticals (NASDAQ:AMRX) received FDA approval for four additional iohexol presentations targeting a U.S. market with approximately $706 million in annual sales.

The approvals expand Amneal’s existing 300 mg iodine/mL 100 mL product, which received FDA authorization in November 2025.

The new products include 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials and 300 mg iodine/mL in a 50 mL vial.

Amneal plans a Q3 2026 launch and said the broader range should provide hospitals and imaging centres with additional presentation and supply options.

Following the announcement, Amneal's share price was up 4.88% at $18.04.

Amneal said the products are the first generic versions referencing OMNIPAQUE across the approved presentations, following its initial first-generic approval in 2025.

Iohexol supports several adult and paediatric imaging procedures, but its label warns that using the wrong concentration intrathecally can cause serious or fatal reactions.