FDA Denies Vanda Petition on Generics of Schizophrenia Drug Fanapt

The FDA rejected Vanda Pharmaceuticals petition to delay the approval of ANDAs referencing its schizophrenia therapy Fanapt until its three-year market exclusivity for a new indication expires.

The agency disagreed with the company’s argument that its exclusivity protected the deletion of claims made in a previously approved label for Fanapt. Those claims stated that there was limited information to warrant the long-term use of Fanapt to treat schizophrenia.

Citing federal statute, the FDA said that “exclusivity does not automatically” apply to all label changes made after a new indication is approved. Determining the scope of the exclusivity is up to the discretion of the FDA, because the statute does not expressly set parameters for determinations.