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
» Consumer Health Information 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 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
SAFETY ALERTS/RECALLS
Food Recall:
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.
This week's spotlight consumer updates are:
http://www.fda.gov/consumer/updates/latexglove042508.html
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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