Recent

% | $
Quotes you view appear here for quick access.

Zogenix, Inc. Message Board

  • lizconti@rocketmail.com lizconti May 9, 2013 8:14 PM Flag

    From Zogenix Website

    Roger Hawley, chief executive officer of Zogenix, stated, "We recently had an update call with the FDA regarding the status of the Zohydro ER new drug application (NDA). On the call, the FDA indicated that they are preparing to take action on the Zohydro NDA in the summer 2013. While they declined to provide any specific reasons for the delay, we have concluded the FDA are working on several broader opioid-related issues that need to be addressed prior to an action on our NDA. We were not informed of any deficiencies in the application, which suggests that the remaining steps in the review process are finalizing the Zohydro ER REMS, to be consistent with the updated class-wide REMS, and labeling discussions. We are disappointed with the ongoing delay, and remain prepared to launch the product three to four months after potential approval."

    SortNewest  |  Oldest  |  Most Replied Expand all replies
 
ZGNX
19.31+0.82(+4.43%)Jul 30 4:00 PMEDT