FDA News Digest for May 12, 2008

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

Title: FDA News Digest for May 12, 2008

FDA News Digest

May 12, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- Generic Versions of Restless Legs Syndrome Treatment Approved

    -- FDA OKs Room Temperature Formulation of Blood Clotting Therapy

»  Congressional Testimony

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Generic Versions of Restless Legs Syndrome Treatment Approved

FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate-to-severe restless legs syndrome. The approval covers a variety of dosages. Four companies have received approval to market the tablets.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01832.html

 

FDA OKs Room Temperature Formulation of Blood Clotting Therapy

FDA has approved a new formulation of the genetically engineered version of Factor VIIa, used to treat bleeding and prevent surgical bleeding in patients with hemophilia A or B. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. This is helpful for healthcare facilities with limited refrigerated space, and it allows greater flexibility in disease management for both patients and doctors.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01833.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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CONGRESSIONAL TESTIMONY

 

May 1 -- FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., appeared before the House Subcommittee on Health.

    Subject: "Discussion Draft of The ‘Food And Drug Administration Globalization Act’ Legislation: Drug Safety"

http://www.fda.gov/ola/2008/fdaglobalact050108.html

 

April 29 -- FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., appeared before the House Subcommittee on Oversight and Investigations.

    Subject: FDA's ongoing heparin investigation

http://www.fda.gov/ola/2008/heparin042908.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

 

Food Recall:

 

› Little Bay Baking and GFCFDiet Corn Bread and Muffin Mix, 12.6-oz. size

Reason for recall: may contain soy not declared on the label

http://www.fda.gov/oc/po/firmrecalls/littlebay05_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

 

For a complete list of upcoming meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

 

 

CONSUMER HEALTH INFORMATION

 

This week's spotlight consumer updates are:

 

›  New Type of Latex Glove Cleared

http://www.fda.gov/consumer/updates/latexglove042508.html

›  Device Identifies Fatty Deposits in Coronary Arteries

http://www.fda.gov/consumer/updates/arteries050108.html

 

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

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

 

 

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