FDA News Digest

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FDA News Digest

August 4, 2008

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IN THIS WEEK'S ISSUE

» News

-- FDA Clears Test That Helps Identify Type of Cancer in Tumor Sample

-- Generic Versions of Depakote OK'd for Seizures, Migraines, Bipolar Disorder

-- Federal Agents Seize More than $24 Million in Unapproved New Drugs

-- Report Identifies Factors Related to FDA Approval Decisions in First-Cycle Reviews

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

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NEWS

FDA Clears Test That Helps Identify Type of Cancer in Tumor Sample

FDA has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01870.html

Generic Versions of Depakote OK'd for Seizures, Migraines, Bipolar Disorder

FDA has approved the first generic versions of Depakote delayed-release tablets (divalproex sodium) for treatment of seizures, migraine headaches, and bipolar disorder. The generic versions will have the same safety warnings as the name brand versions.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01867.html

Federal Agents Seize More than $24 Million in Unapproved New Drugs

FDA representatives and U.S. marshals have seized $24.2 million worth of unapproved new drugs from St. Louis-based KV Pharmaceutical Co. The seizure followed an inspection of company plants that showed the company was manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01868.html

Report Identifies Factors Related to FDA Approval Decisions in First-Cycle Reviews

A final report of FDA’s first-cycle review performance is available online. This study identifies factors that contribute to and detract from FDA’s ability to make approval decisions during the first-cycle review for products that are ultimately approved without major new data submissions.

http://www.fda.gov/ope/pdufa/PDUFA1stCycle/default.htm

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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SAFETY ALERTS/RECALLS

For a complete 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. 8-10 -- Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference

Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/new_conferences_2008_PDA_FDA.aspx?articleid=1453&zoneid=190

Sept. 10-12 -- Parenteral Drug Association (PDA)/FDA Pharmaceutical Ingredient Supply Chain Conference

Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/2008_PDA-FDA_Pharmaceutical_Ingredient_Supply_Chain_Conference.aspx?articleid=1803&zoneid=233

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.

CONSUMER HEALTH INFORMATION

Consumer updates in the spotlight this week are:

› Living with Fibromyalgia, Drugs Approved to Manage Pain

http://www.fda.gov/consumer/updates/fibromyalgia062107.html

› Stronger Warnings Requested for Fluoroquinolones

http://www.fda.gov/consumer/updates/fluoroquinolone070908.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.

Check out "Andy's Take," a commentary from FDA's commissioner.

Go to http://www.fda.gov/oc/vonEschenbach/andys_take/default.html

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