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Court Blocks Generic|Version of ADHD Drug

(CN) - The D.C. Circuit blocked a generic version of Vyvanse, a drug to treat attention deficit hyperactivity disorder, saying the name-brand drug maker's five-year period of market exclusivity hasn't expired.

The Food and Drug Administration approved Vyvanse in 2007. Two years later, Actavis applied for the generic version, but the FDA returned its application unfiled, saying Vyvanse was entitled to five years of exclusivity as a pioneer drug.

Actavis challenged this determination in federal court, seeking to force the FDA to accept its application and rescind its grant of exclusivity to Vyvanse maker Shire Pharmaceuticals.

But the FDA remained firm, and a federal judge upheld the agency's conclusion.

The federal appeals court in Washington, D.C., agreed and rejected Actavis' appeal.

"There is little to Actavis' argument that the award of the five-year exclusivity to Vyvanse conflicted with the FDA's regulations," Senior Circuit Judge A. Raymond Randolph wrote for the three-judge panel.

"We are hard-pressed to second-guess the FDA's view, especially since it 'rests on the agency's evaluations of scientific data within its area of expertise,'" Randolph added, quoting Serono Labs Inc. v. Shalala, a 1998 decision by the D.C. Circuit.


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