Clinical dermatology company, Botanix Pharmaceuticals (ASX:BOT) has submitted the last label materials to the US Food & Drug Administration (FDA) for the approval of Sofdra™ a pending prescription treatment for excessive underarm sweating.
Botanix, which is based in Phoenix and Philadelphia, described the label discussion phase as the final step for Botanix before the anticipated FDA approval of Sofdra and said this involved discussions on product carton design and wording of information that is provided to patients and physicians about the product.
Botanix said FDA-approval for Sofdra remains on target for 21 June, 2024 and success would represent the approval of a chemical entity for excessive underarm sweating, known as primary axillary hyperhidrosis.
Botanix Chief Executive Officer, Howie McKibbon, commented: “Our team has been highly focused on completing these last label components, well in advance of approval.”
“Our label and packaging materials are an important part of the materials that we will use to communicate important safety and efficacy information upon approval of Sofdra.”
BOT was trading flat at 27.5 cents.