Canada Seeks to Alleviate EpiPen Shortage with US Alternative

Regulatory NewsRegulatory News | 30 August 2018 |  By 

Following last month’s notice on an anticipated “very limited” supply of a Pfizer’s EpiPen in Canada, a new interim order allows for immediate importation and sale of a US alternative.
The Minister of Health signed an interim order this week to alleviate the ongoing shortage of Pfizer Canada’s EpiPen 0.3 mg by permitting supplies of Auvi-Q in 0.15 mg and 0.3 mg doses.
Pfizer Canada has attributed the shortage of its EpiPen formats to manufacturing issues. Yet its famously overpriced EpiPen has been in short supplies globally “for several months” over these issues and “it is unclear when the situation will be resolved,” according to Health Canada.
The order came a few weeks after the Canadian regulatory authority issued a notice to inform that “Pfizer Canada does not expect to be able to provide new supply until the end of August.” It will remain effective for two weeks, pending approval for an extension of up to one year.
Manufacturer Kaléo previously received US Food and Drug Administration approvals for several different doses of its Auvi-Q auto-injector. The latest US FDA approval was obtained in November 2017 for Auvi-Q in 0.1 mg format as “the first and only epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions,” according to Kaléo.
Auvi-Q in the same dose formats covered under Canada’s new interim order were subject to a 2015 US voluntary recall initiated by Sanofi US, which subsequently terminated its US and Canadian license and development agreement with Kaléo in 2016.
“As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada,” Sanofi US previously said in announcing the recall.
Immediate importation and sale of the Auvi-Q auto-injectors under the new interim order is limited to “use in the emergency treatment of life-threatening reactions in people who are at risk of or have a history of anaphylaxis. for emergency treatments,” Health Canada said Wednesday.
Kaléo said Wednesday its EpiPen alternative will be available in the Canada market by 7 September. The company also intends to work with Health Canada for the return of a similar product to Auvi-Q, known as Allerject, that was recalled by Sanofi Canada in 2015.
“The primary difference between Auvi-Q and Allerject is that the U.S. product does not include French labelling and instructions,” Health Canada clarified. “An English and French instruction sheet for consumers will be provided with the Auvi-Q product at the time of sale to help ensure that patients and caregivers administer the drug safely and effectively.”


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