FDA Smacks Down Vanda's Bid To Block Fanapt Generics

Law360, New York (December 1, 2016, 8:39 PM EST) -- Vanda Pharmaceuticals Inc. cannot use new exclusivity for its schizophrenia medication Fanapt to block generic versions of the product, the U.S. Food and Drug Administration said in a decision released Wednesday.

The FDA’s decision rejected a citizen petition that D.C.-based Vanda filed in September to thwart proposed copycats of Fanapt, the most popular of its two approved products. Vanda had argued that its three-year exclusivity for long-term use of Fanapt bars generics until 2019. But the FDA disagreed.

Specifically, the FDA on Wednesday shot down assertions...
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