FDA News Digest for September 10, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

September 10, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    --  Generic Versions OK'd of Blood Pressure/Heart Failure Drug Coreg

    --  FDA Warns Tenn. Company About Illegal Sale of Melanotan II

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Generic Versions OK'd of Blood Pressure/Heart Failure Drug Coreg

FDA has approved the first generic versions of Coreg (carvedilol), a widely used drug for treating high blood pressure, mild-to-severe chronic heart failure, and left ventricular dysfunction following a heart attack. Generic drugs use the same active ingredients as brand-name drugs and work the same way, FDA says.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01695.html

 

FDA Warns Tenn. Company About Illegal Sale of Melanotan II

FDA has sent a warning letter to the Tennessee-based marketer of Melanotan II because the product is being marketed and sold illegally as a tanning agent and preventative against skin cancer. FDA considers the product to be an unapproved drug, and the agency urges consumers to stop using it.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01694.html  

 

To view an archive of past 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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SAFETY ALERTS/RECALLS

Dietary Supplement Recall:

 

›  Zencore Tabs

   Reason for recall: FDA analysis found the product contains potentially harmful ingredients not listed in labeling

http://www.fda.gov/oc/po/firmrecalls/bodee08_07.html

 

Food Recall:

 

›  Certain lots of Rimmer brand Mojito Cocktail Garnish

    Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/stirrings08_07.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

Sept. 11-12 -- Joint meetings of the FDA Cardiovascular and Renal Drugs Advisory Committee and the FDA Drug Safety and Risk Management Advisory Committee

    Under discussion: use of erythropoeisis-stimulating agents when treating anemia due to chronic kidney failure (Sept. 11) and clinical data for a product to reduce blood loss in patients undergoing cardiopulmonary bypass surgery (Sept. 12)

    Location: Gaithersburg, Md.

Sept. 11 -- http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14086.htm

Sept. 12 -- http://www.fda.gov/ohrms/dockets/98fr/e7-14151.htm

 

Sept. 19-20 -- FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a product to reduce adhesion formation in patients undergoing cardiac surgery (Sept. 19) and clinical trial designs for cardiac ablation devices designed to treat patients with medically unresponsive atrial fibrillation (Sept. 20)

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14600.htm

 

Sept. 24-28 -- Parenteral Drug Association/FDA Joint Regulatory Conference (including exhibition and training courses)

    Conference title: "Evolution of the Global Regulatory Environment: A Practical Approach to Change"

    Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/new_conferences_2007pdafda.aspx?articleid=923&zoneid=149 

 

Oct. 1 -- Interagency Working Group on Import Safety

    Under discussion: key challenges/actions for industry, consumers, and governments to ensure the safety of imported products

    Location: Washington, D.C.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-17305.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

 

FDA's Web site features a page with information for consumers. Each week in FDA News Digest, we will spotlight material from that page by offering links to timely articles about FDA activities and products the agency regulates.

 

Here's what's in the spotlight this week:

 

›  Building a Stronger Defense Against Bioterrorism

http://www.fda.gov/consumer/updates/bioterror082907.html

›  CARVER + Shock: Enhancing Food Defense

http://www.fda.gov/consumer/updates/carvershock061107.html

›  Improving Access to HIV/AIDS Drugs Abroad

http://www.fda.gov/consumer/updates/pepfar081307.html

 

FDA also has created a free monthly e-newsletter for consumers that contains information posted on the consumer health Web page. To subscribe, go to http://www.fda.gov/consumer/consumerenews.html.

 

For those who are members of the press or who manage Web sites, we encourage you to link to this information or incorporate it into your online or printed publications. (We'd appreciate a credit to "FDA Consumer Health Information.")

 

Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.  

 

 

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