Akorn's downfall amplifies shortage of asthma med albuterol, FDA warns

Supplies of the popular asthma med albuterol will remain tight in the aftermath of Akorn Pharma’s fall.

Akorn, the “sole manufacturer” of a certain dose of liquid albuterol, has stopped production, FDA tweeted Wednesday.  Two weeks ago, Akorn filed for bankruptcy and mothballed its U.S. operations. The closure swept up facilities like Akorn’s Decatur, Illinois, manufacturing plant, which was licensed to make the specific form of the drug in shortage.

Liquid albuterol—which is inhaled via nebulizer to increase air flow to the lungs—has been running scarce since autumn, according to the FDA. The regulator lists just two domestic suppliers for the drug: South Carolina’s Nephron Pharmaceuticals and the now-defunct Akorn. Nephron’s product is listed as “unavailable” on the FDA’s drug shortage database.

Importantly, albuterol inhalers for personal use are not affected by the squeeze.

The FDA stressed that the shortage is limited to a “very specific dosage form of the medication” that’s typically used in hospitals. “All other strengths and vial sizes” remain on tap to meet hospital demand and more, the FDA said.

The regulator says it’s been working with manufacturers and others in the supply chain to mitigate any related fallout from the shortage.

The FDA also recommended hospitals call on outsourcing pharmacies to meet needs as it “continues to explore all available regulatory levers to help assure supply." Those measures could also include imports from foreign drugmakers, the FDA said.

Prior to Akorn’s demise, the company hadn’t been shipping bottles of liquid albuterol for "several months," hospital group purchaser Premier told The Washington Post last week.