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Prior Defects Could Sink Auvi-Q Even As EpiPen Prices Soar

Posted in FDA, Legislation and Public Policy, Life Sciences, Medical Devices, Pharmaceuticals

Day Pitney healthcare attorney Eric Fader was quoted in an October 31 article, “Prior Defects Could Sink Auvi-Q Even As EpiPen Prices Soar,” in Law360. In the article, Eric pointed out that with lawmakers and consumers calling for a competitor to challenge Mylan NV in the aftermath of the drugmaker’s EpiPen price increases, potential competitor Kaléo Pharma has a “golden opportunity” with its updated version of the Auvi-Q epinephrine injector. However, past manufacturing problems with Auvi-Q may make the new product a tough sell.

French pharma giant Sanofi-Aventis SA’s version of Auvi-Q was withdrawn from the market in 2015 when it was found to deliver inconsistent doses of the drug. “As much trouble as Mylan has had, you don’t hear about EpiPens delivering inconsistent amounts of the drug,” Eric said. “It’s not like [Kaléo] figured out a way to deliver the drug consistently and safely but also more economically. If anything they’re going to have their work cut out for them competing on price without risking the same kind of quality control problems they already had.”

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