Complete Response Letters
Botanix SB Inc.: sofpironium bromide
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Sep 22, 2023
Drug, and Cosmetic Act for sofpironium bromide.
CRL_NDA217347_20230922:p1:s12We also acknowledge receipt of your amendment dated September 13, 2023, which was not reviewed for this action.
CRL_NDA217347_20230922:p1:s13Based on the evaluation of the human factors (HF) study results, the user interface does not support the safe and effective use of the proposed product.
CRL_NDA217347_20230922:p1:s19More Complete Response Letters
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