FDA denies Eisai, UCB efforts to tweak exclusivity timing
By Michael Fitzhugh
Monday, May 5, 2014
The FDA has denied citizen's petitions filed by Eisai Inc. and UCB Inc. to change how the agency sets the five-year exclusivity clock for new chemical entities (NCEs) that require Controlled Substances Act (CSA) scheduling, stating that the approach the petitioners suggested is unworkable under current regulations.
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