Zogenix Unlikely to Receive Action Letter for NDA for Zohydro ER by PDUFA Goal Date of March 1, 2013
Zogenix (NASDAQ: ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for ZohydroTM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013. Under the performance goals set by the FDA under PDUFA, the agency can miss the prescribed goal date for approximately ten percent of the NDAs that are submitted each year and still meet the performance goals for review of priority and standard applications.
The FDA has not provided Zogenix with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. Zogenix has not been informed of any deficiencies in the application during the review process to date.
"We are confident in the Zohydro ER program and our NDA submission and are committed to working with the FDA while it completes its review," said Stephen Farr, Ph.D., president