EpiPen competitor the Auvi-Q is coming back on the market, its manufacturer said Wednesday.
Pharmaceutical company Kaléo announced that it is bringing back the Auvi-Q epinephrine auto-injector after a voluntary recall took it off the market last year because the auto-injectors could “potentially have inaccurate dosage delivery,” the FDA said.
Kaléo said the Auvi-Q will be back on pharmacy shelves in the first half of next year. The company emphasized its investment in a high-tech, robotic production line and more than 100 automated quality checks, and said the credit-card shaped device has safety features including voice prompts and an automatically retracting needle.
More competition in the market for lifesaving epinephrine medications that treat anaphylaxis is something serious allergy patients and their families have been waiting for, as EpiPen manufacturer Mylan enjoyed its near-monopoly status and hiked prices by more than 500% since 2008.
Mylan’s $600 list price for a pack of two EpiPens provoked outrage and CEO Heather Bresch was called to testify in front of Congress to explain the sky-high price for a product some analysts say could cost as little as $20 per auto-injector to make.
In a release, the company said it “is working to engage with various stakeholders, including wholesalers, insurance companies, pharmacies and pharmacy benefit managers, to ensure that all patients regardless of insurance coverage, have affordable access,” but no list price has been set yet, the New York Times reports.
Mylan also said it would be bringing out a generic EpiPen priced at $300 for a two-pack by the end of the year, although critics were quick to point out that the drug company might actually make higher profits on that.