Long Grove Pharmaceuticals® acquired the AK-FLUOR® (Fluorescein Injection, USP) NDA in June 2023. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature, and it is available as a sterile solution in the following concentrations:
- 10% (100mg/mL 5mL vials) 12 pack
- 25% (250mg/mL 2mL vials) 12 pack
Fluorescein Injection, USP is currently impacted by a supply shortage resulting from Akorn Pharmaceuticals’ exit from the U.S. market. To ensure the consistent availability of Fluorescein Injection, USP prior to its relaunch as a Long Grove Pharmaceuticals product, Long Grove Pharmaceuticals has reached a distribution agreement with the FDA Office of Drug Shortages through the Regulatory Discretion process. As a result, Long Grove Pharmaceuticals will make available the existing AK-FLUOR inventory manufactured by Akorn Pharmaceuticals in both 10% and 25% solutions.
For more details, see below.