The FDA granted a distribution agreement to Long Grove Pharmaceuticals to enable it to fill a critical supply shortage of fluorescein injection, USP (AK-Fluor), a diagnostic contrast agent frequently used in various ophthalmic procedures.
In June 2023, Long Grove acquired the New Drug Application for AK-Fluor. The company has reached a distribution agreement with the FDA Office of Drug Shortages to make available existing inventory of fluorescein manufactured by Akorn Pharmaceuticals, which went bankrupt in February. The bankruptcy resulted in a shortage of fluorescein injection.
AK-Fluor is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. It is available in the following presentations:
- 10% (100 mg/mL, 5-mL vials) 12 pack
- 25% (250 mg/mL, 2-mL vials) 12 pack
To ensure the consistent availability of fluorescein injection prior to its relaunch as a Long Grove product, the company will make available the existing AK-Fluor inventory manufactured by Akorn in both 10% and 25% solutions.
“Our goal is to provide the market a consistent supply of this essential medication now and after its relaunch as a Long Grove-labeled product,” said Peter Karas, the chief commercial officer at Long Grove. “Until we can fill the gap in supply through our own manufacturing, the existing Akorn-manufactured product will assist in easing procurement burdens for ophthalmic providers and health systems.”
For more information about Long Grove and AK-Fluor, visit www.longgrovepharma.com.
Long Grove was established in 2019 as part of Capstone Development Services, which has been developing products in partnership with the pharmaceutical and medical device organizations since 2013. Combining decades of collective leadership experience with a portfolio of specialized, complex generic drug formulations, Long Grove is poised to innovate across the generic injectable and topical markets.
—From company press materials
