FDA News Digest for February 25, 2008

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest for February 25, 2008

 

FDA News Digest

February 25, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- Treatment Licensed to Help Control, Prevent Bleeding in Hemophilia A Patients

    -- Companies, Executives Prohibited from Making Products with Disease Claims

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Treatment Licensed to Help Control, Prevent Bleeding in Hemophilia A Patients

FDA has licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals -- almost exclusively males -- in the United States. The treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of a protein essential for blood clotting that is missing or decreased in patients with hemophilia A. Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in hemophilia A patients. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01799.html 

 

Companies, Executives Prohibited from Making Products with Disease Claims

Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences), and two company executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with label claims to cure, treat, mitigate or prevent diseases. The companies have agreed to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain such claims. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01800.html

 

To view an archive of recent 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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SAFETY ALERTS/RECALLS

Food Recalls:

 

› Mayfield Vanilla Classic Ice Cream, half-gallon size

Reason for recall: pecans in product not declared on label

http://www.fda.gov/oc/po/firmrecalls/mayfield02_08.html

› Pierre's Homestyle Dutch Chocolate Ice Cream, 56-oz. size

Reason for recall: may contain peanut component not declared on label

http://www.fda.gov/oc/po/firmrecalls/pierre02_08.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

 

Feb. 27-28 -- Anti-Infective Drugs Advisory Committee

    Under discussion: two pending applications for skin/skin structure infection treatments

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-343.htm

 

March 11 -- Anesthetic and Life Support Drugs Advisory Committee

    Under discussion: pending application for a new drug

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-1239.htm

 

March 12-13 -- Oncologic Drugs Advisory Committee

    Under discussion: pending license application for a biological treatment

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-1295.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, we offer links to timely articles about FDA activities and products the agency regulates. In the spotlight this week:

 

›  Icy Hot Heat Therapy Products Recalled

http://www.fda.gov/consumer/updates/icyhot_recall021908.html

›  Charges Filed in Contaminated Pet Food Scheme

http://www.fda.gov/consumer/updates/pet_food021908.html

To receive all consumer updates, go to

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

 

 

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