Amneal Secures FDA Approval for Additional Generic Iohexol Injection Vial Presentations, Expanding Contrast Media Portfolio
Key Insights
Amneal received FDA approval for four additional generic iohexol injection vial presentations, including 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, and 300 mg iodine/mL in a 50 mL vial.
The newly approved products are the first generic versions referencing OMNIPAQUE across these strengths and vial presentations, with launch expected in Q3 2026.
The expanded portfolio is expected to address the majority of U.S. market demand for iohexol injection, which totaled approximately $706 million in annual sales per IQVIA data.
Amneal Pharmaceuticals Inc. (Nasdaq: AMRX) announced Friday that it has received U.S. Food and Drug Administration approval for additional strengths and vial presentations of its generic iohexol injection, significantly expanding the company's injectable contrast media portfolio. The newly approved products include iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, as well as 300 mg iodine/mL in a 50 mL vial.
These latest approvals complement Amneal's previously approved and launched iohexol injection 300 mg iodine/mL in a 100 mL vial. According to the company, the newly approved presentations are the first generic versions referencing OMNIPAQUE — a registered trademark of GE HealthCare — across the approved strengths and vial presentations.
Arash Dabestani, Senior Vice President at Amneal, stated: "It expands our injectable contrast portfolio with the additional strengths of iohexol injection, which commits us to deliver high-quality, reliable medicines that support patient care."
The company expects to launch the newly approved products in the third quarter of 2026. Amneal noted that the expanded portfolio is expected to address the majority of U.S. market demand for iohexol injection while providing hospitals, imaging centers, and healthcare providers with greater supply flexibility.
According to IQVIA, U.S. annual sales of iohexol injection totaled approximately $706 million for the 12 months ended May 2026, underscoring the substantial market opportunity for these generic presentations.
Clinical Profile and Indications
Iohexol is an iodinated radiographic contrast agent indicated for a broad range of diagnostic imaging procedures in adults and pediatric patients aged two weeks and older. The agent can be administered via multiple routes, including intrathecal, intra-arterial/intravenous, oral, and body cavity administration, depending on the imaging requirements.
The most commonly reported adverse reactions vary by route of administration. For intrathecal administration, these include headache, nausea, back/neck pain, and dizziness. Intra-arterial and intravenous routes are associated with chest pain, arrhythmias, blurred vision, photomas, and altered taste. Oral administration may result in nausea, vomiting, diarrhea, and abdominal discomfort, while body cavity administration can cause local pain, swelling, and heat sensation.
Company Background
Amneal Pharmaceuticals, headquartered in Bridgewater, New Jersey, is a diversified global biopharmaceutical company founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel. The company maintains a diverse portfolio of approximately 300 complex generic, specialty, and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States. Its Affordable Medicines segment spans retail generics, injectables, and biosimilars, while its Specialty segment provides branded treatments in neurology — including Parkinson's disease and migraine — and endocrinology.
Amneal shares closed Thursday at $18.04, up 4.88%, with pre-market trading on Friday showing an additional 0.83% gain at $18.19.