As a shortage of epinephrine pens continues to grip the U.K., authorities have agreed to extend the expiration date on a second injector to help ease the situation.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is deciding this month which batches of its Jext pens can have the expiration extended by four months while more are being manufactured. The company said it has provided additional stability data to the agency to help with the processes.
Pharmaceutical company ALK estimated there are more than 100,000 Jext pens currently in circulation in the U.K. that will soon expire.
“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,” said Søren Niegel, ALK’s executive vice president of operations.
U.K. authorities late last month did the same thing for Mylan's 0.3 mg auto-injector EpiPens, supplies of which have been short around the globe since manufacturing issues were discovered by the FDA at the Pfizer plant which manufactures them for Mylan. The MHRA also has put restrictions on who can be prescribed pens until the shortage is resolved.
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