Botanix has today announced that it has received formal written communication from the FDA, confirming that the New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.
With the NDA now formally under review, and a standard review period confirmed, Sofpironium Bromide remains on track for approval in 3Q, 2023.
Botanix President and Executive Chair, Vince Ippolito, said:
“We are very pleased that the NDA for Sofprionium Bromide has been accepted for substantive review by the FDA. Our team has worked diligently to file a comprehensive application and we look forward to the anticipated mid-cycle review in 1Q 2023 and the ultimate approval of Sofprionium Bromide.”