Complete Response Letters
sanofi-aventis U.S. LLC: Fexinidazole
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Nov 12, 2020
Drug, and Cosmetic Act for Fexinidazole tablets, 600 mg.
CRL_NDA214429_20201112:p1:s14On November 9, 2020, you notified us that you will not be able to submit revised labeling during this review cycle.
CRL_NDA214429_20201112:p1:s17Therefore, an agreement could not be reached regarding product labeling.
CRL_NDA214429_20201112:p1:s18To address this deficiency, submit draft labeling that addresses our proposed revisions to the labeling communicated to you via email on November 4, 2020.
CRL_NDA214429_20201112:p1:s19More Complete Response Letters
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