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Home » Actavis Sues FDA Over Vyvanse Application Refusal
Actavis Sues FDA Over Vyvanse Application Refusal
March 6, 2009
Actavis Elizabeth is suing the FDA for refusing to file the company’s ANDA for a generic version of Shire’s attention deficit hyperactivity disorder treatment Vyvanse because the brand drug’s new chemical entity (NCE) exclusivity was still in effect.