FDA News Digest for July 3, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

July 3, 2006

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IN THIS WEEK'S ISSUE

»  News

    --  Generic Version of Depression Treatment Zoloft Approved

    --  New Treatment OK'd for 'Wet' Age-Related Macular Degeneration

    --  Tentative Approval Given to 3-Part Drug Targeted for AIDS Relief

    --  Infusion Pump Maker Baxter Agrees to Correct Deficiencies

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Generic Version of Depression Treatment Zoloft Approved

FDA has approved the first generic version of Zoloft, a treatment for depression in adults. The approval is for the tablet form and the liquid concentrate form (which has the additional use of treating some anxiety-related disorders). In 2005, Zoloft was the sixth highest-selling brand-name drug in the United States. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01404.html

 

New Treatment OK'd for 'Wet' Age-Related Macular Degeneration

FDA has approved Lucentis, an injectable treatment for "wet" age-related macular degeneration, a retinal disease that can cause irreversible vision loss. Lucentis is the first product that, when used monthly, can maintain the vision of more than 90 percent of patients.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html

 

Tentative Approval Given to 3-Part Drug Targeted for AIDS Relief

FDA has given tentative approval to a three-ingredient drug treatment for HIV infection. The product combines the HIV drugs Epivir, Retrovir, and Viramume. The agency's tentative approval means that though existing patents or exclusivity agreements prevent U.S. marketing of the product, the drug meets FDA's standards for quality, safety, and effectiveness. The new product will now be available for use outside the United States under the President's Emergency Plan for AIDS Relief.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01406.html

 

Infusion Pump Maker Baxter Agrees to Correct Deficiencies

Baxter Healthcare Corp. has agreed to stop manufacturing and distributing all models of the Volumetric Infusion Pump and the Syndeo Patient-Controlled Analgesic Syringe Pump until the company corrects production deficiencies and complies with federal manufacturing requirements. Infusion pumps are electronic devices that control delivery of solutions and medications to patients.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01402.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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RECALLS/SAFETY ALERTS

Food Recalls: 

 

Tina's Monster Banana Muffins (6 oz.) and Tina's Mini Banana Muffin (3 pk.), distributed in the Western United States

    Reason for recall: undeclared walnuts

http://www.fda.gov/oc/po/firmrecalls/tina06_06.html

 

Shernoff's brand Potato Salad; 5-, 10-, and 30-lb. sizes

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/Shernoff06_06.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

July 12 -- FDA Workshop on Testing for Malarial Infections in Blood Donors

    Under discussion: current information that might support donor testing for malaria as part of screening

    Location: Bethesda, Md.

http://www.fda.gov/cber/meetings/malaria071206.htm

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

What are 'hypoallergenic' cosmetics? 
"Hypoallergenic" cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, may be led to believe that these products will be gentler than non-hypoallergenic cosmetics.

  
There are no federal standards or definitions that govern the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA.

The term "hypoallergenic" may have considerable market value in promoting cosmetic products to consumers on a retail basis, but dermatologists say it has very little meaning.

 

For more on cosmetics, go to http://www.cfsan.fda.gov/~dms/cos-toc.html.

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