FDA News Digest for October 23, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

October 23, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Novel Drug Therapy Approved to Treat Type 2 Diabetes

    -- FDA Approves Nasal Spray for Symptoms Related to Hay Fever

    -- FDA, FTC Move to Stop Web Sales of Fraudulent Diabetes Treatments

    -- New Treatment for Advanced Head, Neck Cancer Shows Survival Boost

    -- FDA OKs Claim That Fluoridated Bottled Water May Reduce Cavity Risk

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Novel Drug Therapy Approved to Treat Type 2 Diabetes

FDA has approved Januvia tablets, the first diabetes treatment approved in a new class of drugs that enhances the body's ability to lower elevated blood sugar. FDA approved Januvia for use with diet and exercise to improve blood sugar levels in patients with type 2 diabetes, the most common form of the disease. Type 2 accounts for as much as 95 percent of the nearly 21 million diagnosed cases of diabetes in this country.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01492.html

 

FDA Approves Nasal Spray for Symptoms Related to Hay Fever

FDA has approved Omnaris, a nasal spray for the treatment of seasonal or perennial allergic rhinitis, also known as hay fever, in adults and children 12 and older. About 35 million Americans suffer from this condition, which can include symptoms such as watery nasal discharge, fits of sneezing, and itching.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01495.html

 

FDA, FTC Move to Stop Web Sales of Fraudulent Diabetes Treatments

FDA and the Federal Trade Commission are working with Mexican and Canadian officials to stop deceptive Internet marketing of products misrepresented as diabetes cures or treatments. The joint effort has resulted in about 180 warning letters and other advisories being sent to online outlets. About a quarter of the targeted businesses have changed claims or removed their online pages.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01494.html

 

New Treatment for Advanced Head, Neck Cancer Shows Survival Boost

FDA has approved the injected drug Taxotere for use with two chemotherapy drugs, cisplatin and fluorouraocil, to treat patients with inoperable advanced head and neck cancer before undergoing radiation treatments. In clinical trials, the combination therapy prolonged patient survival time by more than four months. Head and neck cancer -- also known as squamous cell carcinoma of the head and neck -- represents about 3 percent of new cancer cases in the United States.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01493.html

 

FDA OKs Claim That Fluoridated Bottled Water May Reduce Cavity Risk

FDA has approved the use of a health claim stating that drinking bottled water containing fluoride may help reduce the risk of dental cavities and tooth decay. The claim is not intended for bottled water products marketed specifically for use by infants.

http://www.cfsan.fda.gov/~dms/flfluoro.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.]

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RECALLS/SAFETY ALERTS

Food Recalls:

 

Hood 100% Apple Juice (distributed in New England states)

    Reason for recall: may contain undeclared milk

http://www.fda.gov/oc/po/firmrecalls/hood10_06.html

 

Various egg salad products under different names distributed by Ballard's Farms Sausage Inc. (Ballard's, Food City, and Valu Time) 

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/ballard10_06.html

 

Duncan Hines Bakery-Style Chocolate Chip Muffin Mix (limited production run affected)

    Reason for recall: may contain undeclared milk

http://www.fda.gov/oc/po/firmrecalls/pinnacle10_06.html

 

Certain Knorr-Lipton "Sides," various sizes

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/unilever10_06.html

 

Medical Device Recall:

 

CoaguChek PT test strips (used to determine blood clotting time of patients taking blood thinners)

    Reason for recall: may cause falsely elevated test results

http://www.fda.gov/oc/po/firmrecalls/roche10_06.html 

 

Safety Alert:

 

(Note: This item is updated from last week) 

FDA is warning consumers not to use counterfeit blood glucose test strips being sold with various models of One Touch brand blood glucose monitors. The counterfeit strips -- certain lot numbers of One Touch Basic Profile and One Touch Ultra -- could give incorrect readings, potentially leading to serious injury or death.

For the latest list of lot numbers and more information, see http://www.fda.gov/bbs/topics/NEWS/2006/NEW01497.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.]

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UPCOMING PUBLIC MEETINGS

Oct. 31 -- Neurological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for approval of a device to treat depression

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8114.htm

 

Nov. 6-7 -- "A Critical Path Approach to Rapid Diagnostics Development and Infectious Disease Treatment"

    Under discussion: shortening the critical path in new product development

    Location: Washington, D.C.

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=11361&eventType=Meeting

 

Nov. 15-16 -- Detroit District Workshop on FDA Clinical Trial Statuary and Regulatory Requirements

    Under discussion: FDA regulation of clinical research conduct, informed consent requirements, other topics

    Location: Indianapolis

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-13114.htm

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

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

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QUESTION OF THE WEEK

 

What is osteoporosis?

Osteoporosis is a disease that causes very weak bones that break easily.  Women are five times more likely to get osteoporosis than men.  There is no way to stop or cure it, but there are things you can do to it slow down.

 

For more information, see http://www.fda.gov/womens/getthefacts/osteoporosis.html. 

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