- Botannix Pharmaceuticals’ (ASX:BOT) resubmission of the NDA for Sofdra has been accepted by the FDA as a complete response
- The FDA confirmed the resubmission was a Class 2 response, meaning it will undergo a six-month review in the hope that approval can be granted in late June 2024
- Botannix has begun to ramp up its commercial launch preparation activities
- BOT shares are up 1.43 per cent, trading at 17.8 cents at 12:04 pm AEDT
Botannix Pharmaceuticals’ (ASX:BOT) resubmission of the new drug application (NDA) for Sofdra has been accepted by the FDA as a complete response.
The resubmission focused on the instructions for use, with no other efficacy, safety, pharmacology, non-clinical or chemistry, or other manufacturing and control (CMC) issues identified.
The FDA confirmed the resubmission was a Class 2 response, meaning it will undergo a six-month review in the hope that approval can be granted in late June 2024.
“We are pleased that FDA has confirmed that the resubmission of the Sofdra NDA is acceptable as a complete response and that the anticipated approval date in late June 2024 remains on target,” Botanix CEO Dr Howie McKibbon said.
“This clarity means that our commercialisation activities in preparation for launch can be appropriately designed to ensure a rapid launch of Sofdra, following successful approval from FDA.”
Botannix has begun to ramp up its commercial launch preparation activities, which include testing telemedicine and supply chain elements, as it focuses on engaging US payers around contracting and product pricing.
BOT shares were up 1.43 per cent, trading at 17.8 cents at 12:04 pm AEDT.