MHRA to extend EpiPen expiry dates to tackle shortages

pharmafile | October 18, 2018 | News story | Manufacturing and Production, Sales and Marketing ALK+, Denmark, Mylan, UK, alk, epipen 

The British government has extended the expiry date on epinephrine pens amid a shortage in the UK.

The Danish pharmaceutical company ALK announced that it was working with the Medicines and Healthcare products Regulatory Agency (MHRA) as the agency decides which specific batches of the Jext epipens will receive an extension on their expiry.

ALK estimates that approximately 100,000 Jext pens in circulation in Britain will expire soon.

Søren Niegel, Executive Vice President, Operations at ALK, commented: “ALK is doing all it can to help address the current situation, but the long lead times associated with manufacturing medicines, together with the sheer size of the shortfall in the market, mean that we are unable to ramp up Jext production quickly enough to meet the patient demand.

Nevertheless, we hope today’s news will ease some of the pressure on prescribers and pharmacists, and will offer peace of mind to allergy sufferers who currently carry a Jext pen.”

The announcement comes just a month after UK regulators put extensions on Mylan’s EpiPens expiry. THE US FDA announced similar measures in August.

Louis Goss

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