FDA News -- FDA News Digest for November 26, 2007

FDA News Digest

November 26, 2007

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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

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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

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SAFETY ALERTS/RECALLS