Botanix have posted an update on their progress in regard to FDA approval for Sofdra:

• Botanix has submitted the last label materials to FDA for Sofdra, a treatment for excessive underarm sweating
• Labeling discussions are the final step for Botanix before anticipated FDA approval of Sofdra and have involved discussions with the FDA on product carton design and wording of information that is provided to patients and physicians about the product
• The materials submitted today included the Prescribing Information and Patient Information
• Approval of Sofdra remains on target for 21 June 2024

I was surprised that material is still being submitted this close to approval. I'm not familiar enough with the process to know if this is typical, or suggests more revisions were requested. My understanding is that FDA approval doesn't involve a lot of two way communication so it may well be part of the scheduled process.

A previous announcement mentioned June 20 as the target for approval, but today's announcement refers to June 21. Not sure if this is a change, a typo, or just referring to different timezones (June 20 in US, June 21 here).

[Held]