Business · 13/12/2018
FDA Clears Path for Indocyanine Green for Injection to be Approved via Abbreviated New Drug Applications
The FDA has determined that IC-GREEN (10mg/vial, 40mg/vial, and 50mg/vial) was not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications (ANDAs) for these formulations.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →