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- Botanix Pharmaceuticals (BOT) receives confirmation from the US FDA that its new drug application (NDA) for its sofpironium bromide product is formally in review
- The FDA confirms it identified no filing review issues in the company’s NDA, and the application was sufficiently complete to permit substantive review
- Further, it confirms that an advisory committee meeting is not needed to discuss the application
- A mid-cycle review remains on track for Q1 2023, and Botanix says this means approval for the product is still on track for the September quarter of next year
- Shares in Botanix are trading at 6 cents at 12:55 pm AEDT
Botanix Pharmaceuticals (BOT) has received confirmation from the US Food and Drug Administration (FDA) that its new drug application (NDA) for its sofpironium bromide product is formally in review.
The FDA confirmed it identified no filing review issues in the company’s NDA, and the application was sufficiently complete to permit substantive review.
Further, it confirmed that an advisory committee meeting was not needed to discuss the application.
“We are very pleased that the NDA for sofpironium bromide has been accepted for substantive review by FDA,” Botanix Chairman Vince Ippolito said.
“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 Sofpironium Bromide.”
A mid-cycle review remains on track for Q1 2023 now that the NDA has been formally accepted by FDA and a standard review period has been confirmed, and Botanix said this meant approval for the product was still on track for the September quarter of next year
The review will provide FDA management and review teams with an opportunity to discuss the review status, key findings and other issues relating to the review with Botanix.
Shares in Botanix were trading at 6 cents at 12:55 pm AEDT.
