FDA News Digest for March 3, 2008

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

Title: FDA News Digest for March 3, 2008

 

FDA News Digest

March 3, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- Reflux Disease Treatment Nexium Now Approved for Children Ages 1 to 11

    -- New Drug is First Approved Treatment for Rare Inflammatory Condition

    -- 'FDA Patient Safety News' Video, Podcast Available

»  Congressional Testimony

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Reflux Disease Treatment Nexium Now Approved for Children Ages 1 to 11

FDA has approved Nexium (esomeprazole magnesium) for short-term use in children ages 1 to 11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved the drug in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children ages 1 to 11, compared to 20 mg or 40 mg recommended for pediatric patients ages 12 to 17.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01802.html

 

New Drug is First Approved Treatment for Rare Inflammatory Condition

FDA has approved Arcalyst, a drug to help ease the symptoms of certain rare chronic inflammatory diseases. The drug is approved for the long-term treatment of two very rare disorders: familial cold auto-inflammatory syndrome and Muckle-Wells syndrome. These disorders affect about 300 people in the United States. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01801.html 

 

'FDA Patient Safety News' Video, Podcast Available

FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

-- To view video or text version: http://www.fda.gov/psn

-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

 

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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CONGRESSIONAL TESTIMONY

 

Feb. 27 -- FDA Deputy Commissioner Janet Woodcock, M.D., appeared before the House Agricultural, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Subcommittee.

    Subject: "Budget for Evaluating the Safety and Effectiveness of Drugs"

http://www.fda.gov/ola/2008/drugsafety_budget022708.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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SAFETY ALERTS/RECALLS

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

 

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:

 

›  Medications for High Blood Pressure

http://www.fda.gov/consumer/updates/bloodpressure022608.html

›  FDA 101: Human Gene Therapy

http://www.fda.gov/consumer/updates/genetherapy022608.html

 

To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html

 

 

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