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Row over Mylan EpiPen boils down to plastic cap

Firm urges FDA to approve Teva's generic devices only if they were truly equivalent and wouldn't confuse patients

Published Thu, Sep 1, 2016 · 09:50 PM
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Washington

THE lack of a cheaper version of Mylan NV's EpiPen shot may come down to a dispute between drugmakers over a plastic cap.

Unlike Mylan's one-cap EpiPen, Teva Pharmaceutical Industries' proposed substitutable generic version has two caps, including a removable one that covers the spot where its needle extends. In a petition to the US Food and Drug Administration (FDA), Mylan cited that difference as the key reason the agency should reject Teva's generic - which is exactly what happened in February of this year.

Nina Devlin, a Mylan spokeswoman, said the company asked the FDA to approve the competing devices only if they were truly equivalent, and wouldn't pose a risk of confus…

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