FDA News Digest
June 9, 2008
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IN THIS WEEK'S ISSUE
» News
-- New Warning Planned for Diabetic Ulcer Cream Regranex
-- Heartworm Drug ProHeart 6 to Have Limited Return to U.S. Market
-- Repeated Violations Prompt Action Against Seafood Company
» Congressional Testimony
» Safety Alerts/Recalls
» Upcoming Public Meetings
» Consumer Health Information
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NEWS
New Warning Planned for Diabetic Ulcer Cream Regranex
FDA has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use three or more tubes of the product. Regranex is a topical cream for diabetic patients to treat leg and foot ulcers that are not healing.
https://www.fda.gov/bbs/topics/NEWS/2008/NEW01845.html
Heartworm Drug ProHeart 6 to Have Limited Return to U.S. Market
FDA has announced the limited return of a reformulated version of ProHeart 6, a heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions. FDA concurs with the limited return of the drug to the U.S. veterinary market under a risk minimization and restricted distribution program designed to provide for safe, appropriate use of the product while minimizing risk to dogs.
https://www.fda.gov/bbs/topics/NEWS/2008/NEW01844.html
Repeated Violations Prompt Action Against Seafood Company
FDA has taken enforcement action against Minneapolis-based seafood processor Captain's Select Seafood Inc. The action follows the company’s extensive history of violating food and drug law. The company also has violated the agency’s regulations that require seafood processors to develop and implement plans that identify food safety hazards and offer preventive measures to control those hazards.
https://www.fda.gov/bbs/topics/NEWS/2008/NEW01846.html
To view an archive of recent FDA news releases, go to
https://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news releases, go to
https://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See https://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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CONGRESSIONAL TESTIMONY
June 5 -- FDA Center for Veterinary Medicine Director Bernadette M. Dunham, D.V.M., appeared before the House Subcommittee on Health
Subject: Reauthorization of the Animal Drug User Fee Act (ADUFA) and the proposed Animal Generic Drug User Fee Act (AGDUFA)
https://www.fda.gov/ola/2008/userfees060508.html
To view an archive of past testimony by FDA officials, go to
https://www.fda.gov/ola/listing.html
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SAFETY ALERTS/RECALLS
Safety Alert:
› FDA is warning consumers nationwide that a salmonellosis outbreak has been linked to certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.
-- Press release: https://www.fda.gov/bbs/topics/NEWS/2008/NEW01848.html
-- More information: https://www.fda.gov/oc/opacom/hottopics/tomatoes.html
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to https://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go to
https://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
[What is an RSS feed? See https://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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UPCOMING PUBLIC MEETINGS
June 12 -- Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
Under discussion: pending application to market a surgical sealant
Location: Gaithersburg, Md.
https://edocket.access.gpo.gov/2008/E8-9537.htm
For a complete list of upcoming meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to https://www.fda.gov/opacom/hpmeetings.html.
CONSUMER HEALTH INFORMATION
Consumer updates in the spotlight this week are:
› Pregnant Women to Benefit from Better Information
https://www.fda.gov/consumer/updates/pregnancy052808.html
› Contaminated Nipple Cream
https://www.fda.gov/consumer/updates/mommysbliss053008.html
To receive all consumer updates by e-mail, go to https://www.fda.gov/consumer/consumerenews.html.
For the latest in consumer health news from FDA, visit https://www.fda.gov/consumer/default.htm.