Clinical dermatology company, Botanix Pharmaceuticals (ASX:BOT) has submitted the last label materials to the US Food & Drug Administration (FDA) for Sofdra a pending prescription treatment for excessive underarm sweating.
Label discussions are the final step for Botanix before the anticipated FDA approval of Sofdra and have involved discussions with 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.
FDA-approval for Sofdra remains on target for 21 June 2024. Upon approval, Sofdra will be the first new chemical entity approved for excessive underarm sweating, known as primary axillary hyperhidrosis.
Botanix is progressing its lead product Sofdra for the treatment of primary axillary hyperhidrosis through FDA approval.
Sofdra is positioned to be a leading first line and second line therapy and potentially represents a safe and effective new option for patients.
“Our team has been highly focused on completing these last label components, well in advance of approval,” CEO, Howie McKibbon, said.
