Keeler USA is partnering with Long Grove Pharmaceuticals to distribute AK-FLUOR (fluorescein injection) for diagnostic fluorescein angiography (FA).
Let’s start with these companies.
As an arm of Halma plc (a global group of safety equipment companies), Keeler USA is based in Malvern, Pennsylvania. Originally launched in 1917, the company operates as a products manufacturer of ophthalmic supplies and equipment serving optometrists and ophthalmologists.
Founded in 2021 and based in Rosemont, Illinois, Long Grove Pharmaceuticals is a pharmaceutical manufacturing company focused on complex generics such as injectables and topical products.
Now AK-FLUOR.
Originally approved by the FDA in 1976, AK-FLUOR is indicated for use duringdiagnostic FA or angioscopy of the retina and iris vasculature.
Available via prescription only, the sterile solution of fluorescein sodium is packaged in the following concentrations:
- 10% (100mg/mL in a 5mL single-dose vial) supplied in a 12 pack
- 25% (250mg/mL in a 2mL single-dose vial) supplied in a 12 pack
See its prescribing info.
So who owns the rights to it?
In June 2023, Long Grove acquired the new drug application (NDA) for AK-FLUOR from Akorn Pharmaceuticals.
And the issue?
A shortage of AK-FLUOR in the United States began in April 2023 following Akorn Pharma’s announcement in February 2023 to file bankruptcy, later recalling 70+ drugs from the U.S. market in May 2023.
Amidst these developments, Akorn ceased production of AK-FLUOR and closed its FDA-inspected manufacturing site.
Now talk about Long Grove’s action on this shortage.
The company issued an update on prescribing information for the diagnostic injection in October 2023, which stated that, effective immediately, Long Grove was coordinating with the FDA to distribute the remaining inventory of AK-FLUOR (in 10% and 25% dose concentrations) that Akorn Pharma had manufactured prior to closing.
See here for the product list.
How does this new partnership come into play?
Through the distribution agreement with Keeler USA, Long Grove will relaunch AK-FLUOR as its own product (sans the Akorn Pharma name).
To note, both companies are currently listing the injection solution in two dose concentrations on their respective websites under the Akorn Pharma name. See here (Keeler USA) and here (Long Grove).
Any idea about the price?
Long Grove’s website doesn’t get into specifics; however, it does require direct orders through the company and three distributors: AmerisourceBergen; Keeler USA; and Medigi. See here (scroll down to the FAQ section).
Per the Keeler website, both dose concentrations clock in at $876.
And the goal?
Per Long Grove CCO Peter Kara, the partnership aims to ease the “procurement burdens of this essential ophthalmic drug.”“Our goal is to provide the market consistent supply of this medication now and after its relaunch as a Long Grove product,” he stated.
Lastly, are there any other companies selling this?
Per the FDA’s drug shortage listing:
As of November 3, 2023, Nexus Pharmaceuticals, LLC is officially offering fluorescein sodium injection in two doses:
- Injection 10%, 500mg/5mL (NDC 14789-122-05)
- Injection 25%, 250mg/mL (NDC 14789-123-05)
And, as of November 9, 2023, Alcon has an “adequate inventory” of fluorescein injection, 100 mg/1 mL (Fluorescite 10%; NDC 0065-0092-65) and is scaling its production to meet the higher demand.