FDA News Digest for November 26, 2007

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 26 Nov 2007 17:09:55 -0600 (CST)

Title: FDA News Digest for November 26, 2007

  FDA News Digest

  November 26, 2007

  ______________________________________

    IN THIS WEEK'S ISSUE

    »  News

        --  Allergy Drug Zyrtec Approved for Nonprescription Use 

    --  FDA Evaluating Adverse Reports for Stop-Smoking Drug 

    --  Agency Approves Drug to Treat Inoperable Liver Cancer

        »  Safety Alerts/Recalls 

        »  Upcoming Public Meetings  

»  Consumer Health Information 

            __________________________________________ 

            NEWS

            Allergy Drug Zyrtec Approved for Nonprescription Use

              FDA has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use. The drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older.  

              http://www.fda.gov/bbs/topics/NEWS/2007/NEW01750.html 

              FDA Evaluating Adverse Reports for Stop-Smoking Drug

              The maker of Chantix (varenicline), a prescription medicine to help adults stop smoking, has submitted reports to FDA describing suicidal thoughts in people taking the drug. FDA is working on an analysis of available information and will communicate conclusions and recommendations when complete. Meanwhile, the agency recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. 

              http://www.fda.gov/bbs/topics/NEWS/2007/NEW01749.html

              Agency Approves Drug to Treat Inoperable Liver Cancer

              FDA has approved Nexavar (sorafenib) for patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for patients with advanced renal cell carcinoma, a form of kidney cancer. According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. 

              http://www.fda.gov/bbs/topics/NEWS/2007/NEW01748.html

            To view an archive of past FDA news releases, go to

              http://www.fda.gov/opacom/hpnews.html.

              To access the RSS feed of FDA news releases, go to

              http://www.fda.gov/bbs/topics/news/rssPress.xml. 

              [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

              ___________________________________________

                SAFETY ALERTS/RECALLS 

                  Food Recall:

                  › Various types of Charlemagne dark chocolate organic bars, 1.75-oz. size

                  Reason for recall: milk component not declared on label

                  http://www.fda.gov/oc/po/firmrecalls/charlemagne11_07.html

                For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

                products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

                To access the RSS feed of FDA recalls information, go to

                http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

                [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

                _____________________________________________

                UPCOMING PUBLIC MEETINGS 

                Nov. 27-29 -- Pediatric Advisory Committee

                    Under discussion: adverse event reports related to the drug Tamiflu (Nov. 27-28); labeling of drugs for lactating women (Nov. 29)

                    Location: Gaithersburg, Md.

                ›  Nov. 27-28: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20302.htm

                ›  Nov. 29: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20304.htm

                For a complete list of FDA meetings, seminars, and other public events, go to

                http://www.fda.gov/opacom/hpmeetings.html.

                  CONSUMER HEALTH INFORMATION

                  Each week in FDA News Digest, we spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates.

                  Here's what's in the spotlight this week:

                  ›  Have You Given Blood Lately?

                  http://www.fda.gov/consumer/updates/blooddonations100407.html 

                  ›  Should Your Child Be in a Clinical Trial?

                  http://www.fda.gov/consumer/updates/pediatrictrial101507.html 

                  If you would like to sign up to receive all consumer updates, go to

                  http://www.fda.gov/consumer/consumerenews.html 

                  Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.  

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