Botanix Pharmaceuticals has today announced the Company’s resubmission of the new drug application (NDA) for Sofdra™ has been accepted as a complete response by FDA. FDA also confirmed that the resubmission of the Sofdra NDA is a Class 2 response (i.e., a 6-month review period from the resubmission in late December 2023), with the result that approval remains on target for late June 2024.
Botanix CEO, Dr Howie McKibbon, said:
“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.
“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.”