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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.