Actavis has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year. FDA’s Orange Book shows that VYVANSE is a Type 1 new molecular entity covered by a period of 5-year New Chemical Entity exclusivity, as well as another period of 3-year exclusivity and two patents scheduled to expire on June 29, 2023.
The details can be read here.
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