EpiPen expiry extension reaches UK shores as supplies dwindle
The move by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) follows on from similar action in the US, where the Food and Drug Administration (FDA) also allowed a four-month extension on the expiry date for specific lots of EpiPen products.
The product in question is the EpiPen 0.3mg auto-injector and relates to products that have expiry dates between July 2018 and November 2018.
Manufacturing issues at the Pfizer plant responsible for producing the products has created an on-going problem that has rumbled on over the last year, which has now severely limited stock of all EpiPen products.
In regards to EpiPen Junior, a specific formulation for children, the MHRA released a statement to healthcare professionals: “Mylan are now out of stock of EpiPen Junior and interruptions in the supply are anticipated to continue for the coming months.”
The MHRA stated that Mylan had notified the agency that it expects to stabilise the supply of EpiPen 0.3mg in the fourth quarter, running from October through to December, of this year. It is not just the UK and US that have been impacted, with supply issues also being faced in Canada.
The manufacturing issues have created an opportunity for competitors looking to bring to market their own epinephrine treatments for allergic reactions.
One such company is Teva, which received approval from the FDA in August for a rival treatment, but informed us, at the time, that the rollout of the new product would be in “coming months” and it is, therefore, unable to provide an immediate solution to the supply issues facing Mylan.
