Key highlights
• Botanix has received confirmation that the NDA application for Sofpironium Bromide is suitable
for substantive review and no filing, review issues were identified
• FDA also confirmed that they do not believe that an advisory committee meeting is required to
discuss the application and that the mid-cycle review meeting remains on track for 1Q 2023
• With the formal NDA filing for Sofpironium Bromide now accepted by FDA and a standard
review period confirmed, approval for the product remains on track for 3Q 2023
Ann: Confirmation Sofpironium Bromide NDA Formally Under Review, page-3
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