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Botanix Pharmaceuticals (ASX: $BOT) completes resubmission of NDA for sofdra

Botanix Pharmaceuticals resubmits NDA for Sofdra ahead of schedule


Botanix Pharmaceuticals Limited (ASX: $BOT) has successfully completed the resubmission of the New Drug Application (NDA) for Sofpironium Bromide gel, 15% ('Sofdra™'). The resubmission, originally planned for 1Q 2024, was accelerated, leading to an earlier filing. The target for FDA approval of Sofdra has been moved up to late 2Q 2024.

Executive Commentary on Sofdra NDA Resubmission


Botanix CEO, Dr Howie McKibbon, expressed his satisfaction with the early completion of the Sofdra NDA resubmission, acknowledging the team's efforts. He emphasized the company's focus on commercialization preparation and collaboration with the FDA towards the midyear approval of Sofdra.

Summary of Botanix Pharmaceuticals Announcement


Botanix Pharmaceuticals has successfully completed the resubmission of the NDA for Sofdra, accelerating the filing ahead of the original schedule. The company's CEO, Dr Howie McKibbon, highlighted the focus on commercialization preparation and collaboration with the FDA for the midyear approval of Sofdra. The resubmission was in response to an FDA complete response letter, with the only deficiency identified being related to the Instructions for Use (IFU) for Sofdra. No additional clinical studies are required to support the resubmission and approval of Sofdra. The target for FDA approval of Sofdra has been moved up to late 2Q 2024, with commercial launch preparation activities already underway. Botanix Pharmaceuticals is positioned to offer a safe and effective new option for patients with primary axillary hyperhidrosis, and it also has a pipeline of other products in late-stage clinical studies for various dermatological conditions.

Sourcehttps://announcements.asx.com.au/asxpdf/20231221/pdf/05ytbkkcqxd35y.pdf

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