Amneal Wins FDA Nod for Expanded Iohexol Line, Tapping $706M Market
AMRX has more than doubled off its 52-week low of $7.665.
Summary
Amneal received FDA approval for additional strengths and vial sizes of its generic iohexol contrast agent, covering 350 mg/mL in 50, 75, and 100 mL vials and 300 mg/mL in 50 mL. The company plans to launch in Q3 2026, targeting a U.S. market worth $706 million annually per IQVIA. This builds on its existing 300 mg/mL 100 mL approval and positions Amneal to capture the majority of iohexol demand. The news adds a new product catalyst to the Kashiv BioSciences acquisition narrative from April, reinforcing the injectables growth story.
At the time of this announcement, AMRX was trading at $18.03 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.8B. The 52-week trading range was $7.67 to $18.08. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.