FDA News Digest
April 25,
2005
___________________________________________________________
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
___________________________________________________________
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
___________________________________________________________
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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