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Home » Eisai Petitions FDA for NCE Exclusivity Date Redo
Eisai Petitions FDA for NCE Exclusivity Date Redo
August 15, 2013
The FDA has robbed Eisai of full exclusivity for two of its products by setting their new chemical entity (NCE) start dates before commercial marketing can begin — a move that is “contrary to the law and congressional intent,” the company says in a citizen petition.