FDA News: FDA News Digest for June 9, 2008

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.

http://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the limited return of a reformulated version of ProHeart 6, a heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions.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.

http://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.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01846.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

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)

http://www.fda.gov/ola/2008/userfees060508.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

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: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01848.html

-- More information: http://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 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

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.