Mylan recalls pricey US EpiPens, but cheaper version unaffected

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There was fresh embarrassment for embattled Mylan after it was forced to recall batches of its EpiPen allergy shot in the US because of a potential defect – while its own cheaper “authorised generic” has been unaffected.

Meridian Medical Technologies, part of Pfizer and Mylan’s manufacturer for the pens, expanded the voluntary recall for the drug to lots distributed in the US and other markets after consultation with the FDA.

In late March, Mylan recalled around 81,000 EpiPens in countries outside the US, including Australia, New Zealand, Europe and Japan, after two reports the device failed to work in emergencies.

A potential defect in a supplier component made the device difficult to operate in an emergency – leading to failure to activate, or increased force needed to activate, Mylan said.

This could have “serious health consequences” for patients experiencing a life-threatening allergic reaction.

Although the defect is extremely rare, the recall is being expanded as a precautionary measure, said Mylan.

Ironically, the recall does not affect Mylan’s cheaper generic version of EpiPen, which was released to counter investigations by US authorities into the high price of the product.

Even though its patent has expired, EpiPen has become a blockbuster after Mylan increased its price over the years.

In autumn, Mylan paid the US government $465 million to settle issues raised related to EpiPen, after CEO Heather Bresch defended pricing in front of the House Committee on Oversight and Government Reform.

To counter the criticism it faced over the $600 tag for a two-pack of EpiPen in the US, Mylan has produced a generic version at a fraction of the original price.

The news hit the company’s share price, which ticked down on the NASDAQ and has also done nothing to improve its reputation.

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The generics firm is also working out how to respond to the FDA’s rejection of its generic version of GlaxoSmithKline’s Advair respiratory drug last week.