Actavis Responds to FDA Request for Comment on Vyvanse Exclusivity

Lawyers representing Actavis Elizabeth have responded to an FDA request for comments to rescind the new chemical entity (NCE) exclusivity for Shire’s attention deficit hyperactivity disorder drug Vyvanse. In its comments, the law firm Axinn, Veltrop & Harkrider LLP says the FDA’s February 2007 grant of NCE exclusivity to Vyvanse (lisdexamfetamine dimesylate) was arbitrary and capricious. The drugmaker asserts that Vyvanse isn’t entitled to the exclusivity because dextroamphetamine, the drug’s active moiety — the molecule or ion responsible for the physiological or pharmacological action of the drug — has been approved in several other NDAs.
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