Enforcement Report - Week of December 21, 2022
Company led drug alert – Iohexol solution for injection (350mg/ml and 300 mgI/ml)
SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) presented positive results today from a Phase 1 clinical trial of its Captisol-enabled (CE) Iohexol program at ASN Kidney Week 2019 in Washington, D.C. The CE-Iohexol program was established in January 2018 to develop a Captisol-enabled, next-generation contrast agent for diagnostic imaging with a reduced risk of renal toxicity. The trial achieved the primary endpoint demonstrating pharmacokinetic bioequivalence between CE-Iohexol injection and a reference Iohexol injection (OMNIPAQUE™) after intravenous (IV) administration in healthy adults. CE-Iohexol injection was safe and well tolerated, and adverse events were in line with the known safety profile of OMNIPAQUE.
SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces completion of enrollment of the Company’s Phase 1 clinical trial of its internal Captisol-enabled (CE) Iohexol program. The CE-Iohexol program is designed to develop a Captisol-enabled, next-generation contrast agent for diagnostic imaging with a reduced risk of renal toxicity. Ligand also provides below a summary of the findings of a survey of clinicians on radiocontrast agent selection and use.
Enforcement Report - Week of December 26, 2018
JCB Laboratories Receives Form 483