Xspray的藥證延遲6-12月

21點 · 2025-10-09T02:19:19Z

The U.S. Food and Drug Administration (FDA) will suspend approvals of new products as long as the facility of Xspray Pharma's contract manufacturer remains subject to corrective actions. The FDA communicated this decision in a so-called Complete Response Letter to Xspray following the company's application for market approval of Dasynoc, according to a press release. The FDA's comments regarding Good Manufacturing Practice (GMP) are reportedly not directed at the production line used for Dasynoc itself, but exclusively at the contract manufacturer. Simultaneously, Xspray announced that the manufacturer has confirmed an action plan is already in place and that a meeting with the FDA is scheduled for December. 我記得Xspray的藥證不是過了？這次出的問題是GMP藥廠的生產線，FDA最快12月才會重新審核。所以被評估上市時間將推遲6-12個月。對漢達來講是天大的好消息。我的疑問是這段時間內，漢達的銷售需要付權利金給Xspray？有高手可以解答？