EmailZogenix (ZGNX $1.33 -1.03) announced that the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 2-11 [with 1 abstention] against the approval of ZohydroTM ER (hydrocodone bitartrate extended-release capsules), an extended-release formulation of hydrocodone without acetaminophen, for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. "Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue," said Stephen Farr, Ph.D., president and chief operating officer of Zogenix. "However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population." The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Zohydro ER New Drug Application (NDA) for approval is March 1, 2013.
than one year.
The Briefing.com RSS (really simple syndication) service is a method by which we offer story headline feeds in XML format to readers of the Briefing.com web site who use RSS aggregators. By using Briefing.com’s RSS service you agree to be bound by these Terms of Use. If you do not agree to the terms and conditions contained in these Terms of Use, we do not consent to provide you with an RSS feed and you should not make use of Briefing.com’s RSS service. The use of the RSS service is also subject to the terms and conditions of the Briefing.com Reader Agreement which governs the use of Briefing.com's entire web site (www.briefing.com) including all information services. These Terms of Use and the Briefing.com Reader Agreement may be changed by Briefing.com at any time without notice.
Use of RSS Feeds:
The Briefing.com RSS service is provided free of charge for
use by individuals, as long as the feeds are used for such individual’s
personal, non-commercial use. Any other uses, including without
limitation the incorporation of advertising into or the placement
of advertising associated with or targeted towards the RSS Content,
are strictly prohibited. You are required to use the RSS feeds
as provided by Briefing.com and you may not edit or modify the
text, content or links supplied by Briefing.com. To acquire
more extensive licensing rights to Briefing.com content please
review this page.
Link to Content Pages:
The RSS service may be used only with those platforms from which
a functional link is made available that, when accessed, takes
the viewer directly to the display of the full article on the
Briefing.com web site. You may not display the RSS content in
a manner that does not permit successful linking to, redirection
to or delivery of the applicable Briefing.com web site page.
You may not insert any intermediate page, “splash” page or any
other content between the RSS link and the applicable Briefing.com
web site page.
Ownership/Attribution:
Briefing.com retains all ownership and other rights in the RSS
content, and any and all Briefing.com logos and trademarks used
in connection with the RSS service. You are required to provide
appropriate attribution to the Briefing.com web site in connection
with your use of the RSS feeds. If you provide this attribution
using a graphic we require you to use the Briefing.com web site
logo that we have incorporated into the Briefing.com RSS feed.
Right to Discontinue Feeds:
Briefing.com reserves the right to discontinue providing any
or all of the RSS feeds at any time and to require you to cease
displaying, distributing or otherwise using any or all of the
RSS feeds for any reason including, without limitation, your
violation of any provision of these Terms of Use or the terms
and conditions of the Briefing.com Reader Agreement. Briefing.com
assumes no liability for any of your activities in connection
with the RSS feeds or for your use of the RSS feeds in connection
with your web site.
