Business · 18/04/2012

FDA Clears Path for Fluorescein Sodium Injection Approval

The Food and Drug Administration (FDA) has determined that FUNDUSCEIN-25 (fluorescein sodium injection, 25%) and AK-FLUOR (fluorescein sodium injection, 25%) were not withdrawn from sale due to safety or effectiveness concerns. This decision enables the FDA to potentially approve abbreviated new drug applications (ANDAs) for fluorescein sodium injection, 25%, pending compliance with all applicable laws and regulations.