FDA News Digest for May 22, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

May 22, 2006

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IN THIS WEEK'S ISSUE

»  News

    --  New Parkinson's Treatment Called 'an Important Addition'

    --  FDA Finalizes Reduced Heart Disease Risk Claim for Barley 

    --  Remicade Approved to Treat Children with Crohn's Disease

    --  Report Details Preliminary Findings of B & L Plant Inspection

    --  Generic Version of Ziagen Tentatively Approved for AIDS Relief

»  Latest FDA Consumer Magazine Available Online 

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

New Parkinson's Treatment Called 'an Important Addition'

FDA has approved Azilect, a new type of drug for treating Parkinson's disease, a degenerative disorder caused by destruction of certain brain cells. The disease often leaves patients unable to initiate and control movement. FDA calls Azilect "an important addition to the physicians' treatment options." About 50,000 Americans are diagnosed yearly with Parkinson's.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01373.html

 

FDA Finalizes Reduced Heart Disease Risk Claim for Barley

FDA has finalized a rule that allows foods containing barley to claim they may reduce the risk of heart disease. To carry the claim, a serving of the food must contain at least 0.75 grams of soluble fiber. The claim also must state that the barley product is "part of a diet low in saturated fat and cholesterol."

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01375.html

 

Remicade Approved to Treat Children with Crohn's Disease

FDA has approved Remicade to treat children with active Crohn's disease, a chronic, inflammatory bowel condition that can be severely debilitating. Though "not a cure," FDA says, Remicade reduces inflammation and provides "a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children." FDA first approved Remicade in 1998 as a Crohn's disease treatment for adults.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01376.html

-- More information: http://www.fda.gov/cder/drug/infopage/infliximab/default.htm

 

Report Details Preliminary Findings of B & L Plant Inspection

Observations from an FDA inspection of a Bausch & Lomb manufacturing plant "do not necessarily support" a connection between the formulation of the company's ReNu with MoistureLoc contact lens cleaner and Fusarium keratitis infections, the agency says. FDA emphasizes that the findings are preliminary, and an investigation will continue. Bausch & Lomb has permanently removed the product from the marketplace worldwide.

-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01372.html

-- Recall notice: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01371.html 

 

Generic Version of Ziagen Tentatively Approved for AIDS Relief

FDA has tentatively approved abacavir sulfate, a generic version of the approved HIV/AIDS drug Ziagen. 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. Abacavir sulfate 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/NEW01374.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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Latest FDA Consumer Magazine Available Online 

 

The May-June issue of FDA Consumer has articles on these topics:

 

» Medical device safety -- FDA aims for a quicker response to device problems.

» Family health history -- A free tool can help determine if you should be screened for certain diseases.

» Prostate health-- A rundown of FDA-approved treatments.

» Restless legs syndrome -- First drug specifically for this disorder has been approved.

» Product recalls-- FDA's process for removing or correcting products.

» Improved cancer treatments-- Three federal agencies are collaborating on targeted therapies.

» Drug safety-- How to keep up with drug warnings and other FDA regulatory actions.

 

The issue is online at http://www.fda.gov/fdac/306_toc.html.

 

Subscribe to the print version of FDA Consumer:  http://www.fda.gov/fdac/orderform/fdap.html

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RECALLS/SAFETY ALERTS

 

Food Recalls: 

 

Certain lots of Cut Cahill's Farm Porter Cheese; 7- and 10-oz. size

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/swissamerican05_06.html

 

Bhavani Golden Raisins; 7-oz. size

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/bhavani05_06.html

 

One lot of R.L. Schreiber's Beef Gravy Mix; 12-oz. size

    Reason for recall: undeclared soy and milk

http://www.fda.gov/oc/po/firmrecalls/schreiber05_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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RECENT SPEECHES

 

May 18 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the 2006 Clinical Research Educational Conference.

    Subject: clinical trials

http://www.fda.gov/oc/speeches/2006/northwestern0518.html

 

To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.

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UPCOMING PUBLIC MEETINGS

May 23 -- Radiological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: FDA's Critical Path Initiative

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12526d052306.html

 

May 23-24 -- 9th Annual FDA-0range County Regulatory Affairs Educational Conference

    Under discussion: approvals, compliance and risk management for drugs, devices and biological industries

    Location: Newport Beach, Calif.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-4092.htm

 

June 2 -- Oncologic Drugs Advisory Committee

    Under discussion: proposed leukemia treatment

    Location: Atlanta

http://www.fda.gov/oc/advisory/accalendar/2006/cder12542d060206.html

 

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 precautions should be taken regarding food safety in the home following a hurricane or flood?

 

FDA urges these precautions:

 

» Do not eat any food that may have come into contact with flood water. If in doubt, throw it out.

 

» Do not eat food packed in plastic, paper, cardboard, cloth, and similar containers that have been water damaged.

 

» Discard food and beverage containers with screw-caps, snap lids, crimped caps (soda bottles), twist caps, flip tops, and home canned foods, if they have come in contact with flood water. These containers cannot be disinfected.

 

» Undamaged, commercially-prepared foods in all-metal cans or retort pouches can be saved if you remove the labels, thoroughly wash the cans, rinse them, and then disinfect them with a sanitizing solution consisting of 1 tablespoon of bleach per gallon of potable water. Re-label containers that had the labels removed, including the expiration date, with a marker.

 

For more information on health and safety measures after a hurricane or flood, see http://www.fda.gov/oc/opacom/hottopics/hurricane.html.

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