Source: Adobe Stock
The Market Online - At The Bell

Join our daily newsletter At The Bell to receive exclusive market insights

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.

BOT by the numbers
More From The Market Online
The Market Online Video

ASX Daily Close: ASX matches futures prediction on a green Friday | 21 June 2024

The ASX200 reversed its trend to end the week in the green, up 0.35%. Nearly all…
The Market Online Video

ASX Market Update: Stocks swing from green with energy to remorseful red | 21 June, 2024

The ASX200 came out the gate in the green on Friday, but slipped well below the red line within the first hour of

Week 25 Wrap: No RBA cut yet; India stocks shake off Modi jitters; China concerns remain

The RBA keeps rates on pause; Guzman Gomez falls nearly -5% on Friday; Droneshield's new ATH;…

Plagues precede widespread power shifts. We’re living in one – and minerals are at the fore

The one defining feature of our post-COVID 'new normal' is a USA swing towards domestic supply…