FDA News Digest for April 25, 2005

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Title: Message

FDA News Digest

April 25, 2005

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IN THIS WEEK'S ISSUE

 

--  Rx Mouth Rinse Treats Gum Disease by Blocking Bacteria on Teeth

--  Operation 'Cyber Chase' Nets 20 Arrests for Illegal Rx Drug Trafficking

--  Oncologist Pazdur to Head New FDA Cancer Office

--  Recalls/Market Withdrawals

--  Public Meetings

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Rx Mouth Rinse Treats Gum Disease by Blocking Bacteria on Teeth

 

FDA has approved Decapinol Oral Rinse to treat gingivitis, a common gum inflammation that affects most adults at some point in their lives. The prescription product creates a barrier on teeth that reduces the number of bacteria that attach to the tooth surface and cause dental plaque. Decapinol is approved for those age 12 and older who have been unable to prevent gingivitis with regular tooth brushing and flossing.

http://www.fda.gov/bbs/topics/news/2005/NEW01174.html

 

Operation 'Cyber Chase' Nets 20 Arrests for Illegal Rx Drug Trafficking

 

A year-long investigation targeting international trafficking of prescription drugs over the Internet has resulted in 20 arrests in eight U.S. and four foreign cities. Those arrested allegedly shipped controlled substances, including narcotics, amphetamines, and anabolic steroids, to buyers of all ages without the medical examination required by law. The investigation, dubbed Operation "Cyber Chase," involved FDA and several other federal agencies, along with state and local law enforcement and authorities in four other countries.

http://www.usdoj.gov/dea/pubs/pressrel/pr042005.html

 

Oncologist Pazdur to Head New FDA Cancer Office

 

FDA has selected Richard Pazdur, M.D., to head its new Office of Oncology Drug Products, which consolidates three previous areas of FDA responsible for oversight of drugs and therapeutic biologics used in cancer treatment and prevention. Pazdur is a veteran FDA manager with a strong career background in clinical and academic oncology.

http://www.fda.gov/bbs/topics/news/2005/NEW01175.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

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RECALLS/MARKET WITHDRAWALS

 

The following products are being recalled for the reasons shown. Go to the linked pages for more information.

 

One lot (40,000 bottles) of epilepsy medicine Neurontin; 100-mg. capsules (capsules may be empty or partially filled)

Though this recall began in February, the notice is to help ensure that all patients have been notified.

http://www.fda.gov/oc/po/firmrecalls/pfizer04_22.html

 

Bon Campo sun-dried tomatoes; 8 oz. (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/merex04_05.html

 

Casale sun-dried tomatoes, regular halves (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/atlantic04_05.html

 

One lot of Jello brand vanilla-flavored Sugar Free, Fat Free, Reduced Calorie Instant Pudding and Pie Filling (undeclared pistachios)

http://www.fda.gov/oc/po/firmrecalls/kraftexpand04_05.html

 

Couque D'asse Coffee Cookies (undeclared dairy, eggs, and hazelnut)

http://www.fda.gov/oc/po/firmrecalls/sikpoomexpand04_05.html

 

Tristar Foods' Dried Sliced Lotus Root (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/tristar04_05.html

 

Trilini International's Fruit Marshmallows (undeclared eggs and acid red food color)

http://www.fda.gov/oc/po/firmrecalls/trilini04_05.html

 

Ho's Trading Inc.'s Home Special Soup Mix; 4 oz. (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/ho04_05.html

 

One lot of Antlermax Deer 20 deer feed; 50-lb. bags (may contain potentially harmful level of monensin sodium)

http://www.fda.gov/oc/po/firmrecalls/purina04_05.html

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 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

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PUBLIC MEETINGS

 

April 26-28 -- 11th Annual FDA Science Forum; includes a free public session on April 26 on personalizing you healthcare; remaining two days are devoted to scientific sessions on nanotechnology, animal models, cancer diagnosis/treatment, risk management, and other topics (Washington, D.C.)

http://www.fda.gov/scienceforum/

 

May 3-4 -- Pharmaceutical Science Advisory Committee; under discussion: establishing drug release or dissolution specifications, and assessment of pharmaceutical equivalence and product design (Rockville, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12539dd05030405.html

 

May 5 -- Oncologic Drugs Advisory Committee; under discussion: application for new drug to treat elderly patients with newly diagnosed poor-risk acute myeloid leukemia (Rockville, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12542d050505.html

 

May 11 -- Drug Educational Forum/Public Workshop; will present information about FDA's premarket requirements to the drug industry, particularly small businesses, startups, and entrepreneurs (Kansas City, Mo.)

http://www.fda.gov/cder/meeting/de-forum-2005.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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