Canada Preps for EpiPen Shortage in August Following Manufacturing Issues

Regulatory NewsRegulatory News | 31 July 2018 |  By 

Health Canada late Monday announced that Pfizer Canada said the supply of EpiPen in the 0.3 mg format is expected to be “very limited” at pharmacies in August. 

“Pfizer Canada does not expect to be able to provide new supply until the end of August. The company has also advised that, at this time, they continue to be able to supply EpiPen Jr (0.15 mg); however, the supply is limited and is being carefully managed at the national level,” Health Canada said.

EpiPen and EpiPen Jr are used to deliver epinephrine to patients who are at risk or have a history of life-threatening allergic reactions, which is known as anaphylaxis. There are currently no alternative auto-injectors available on the market in Canada, Health Canada said.

Pfizer Canada told Health Canada that the shortage is due to a manufacturing issue with the EpiPen 0.3 mg format.

The Health Canada announcement follows a similar announcement from the US Food and Drug Administration (FDA) in May.

“There are intermittent supply constraints due to manufacturing delays from the manufacturing partner, Meridian Medical Technologies, a Pfizer company,” Mylan said in a statement posted to FDA’s drug shortage list. “Mylan is receiving continual supply from MMT and expediting shipment to wholesalers upon receipt. Supply levels may vary across wholesalers and pharmacies.”


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