FDA grants Teva approval for first EpiPen generic

The US Food and Drug Administration (FDA) yesterday granted Teva approval for the first generic version of EpiPen (epinephrine), an autoinjector pen used for the emergency treatment of allergic reactions.

The approval is part of the FDA’s long-standing commitment to advance access to generic alternatives once patents no longer prevent their approval, explained Scott Gottlieb, commissioner of the FDA.

“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” he added.

In June last year, the FDA announced its intention to target the barriers to generic drug competition including by implementing a policy aimed at expediting the review of generic drug applications.

Yesterday, August 16, Gottlieb added that the FDA was committed to the development of generic versions of complex products.

“These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval,” he noted.

To help competition, the FDA is advancing new guidance for sponsors to make the development of generic versions of complex products more efficient. The administration is also prioritising the review of these applications.

Mylan, the maker of EpiPen, paid the US government $465 million in August last year to settle a lawsuit about the classification of the injector under the Medicaid Drug Rebate Program. The US Department of Justice had alleged that the EpiPen was “knowingly misclassified” as a non-innovator drug rather than a branded product.

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