FDA News Digest for September 15, 2003

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FDA News Digest
September 15, 2003
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FDA Takes Action Against Two Companies Importing Unapproved Drugs

FDA has taken action against Rx Depot Inc. and Rx Canada to stop them from
importing drugs that pose a serious threat to the public health. The agency
uncovered a disturbing pattern of actions by these companies resulting in
potentially hazardous errors.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00939.html
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First in New Class of Antibiotics Approved for Treating Skin Infections

FDA has approved the injected drug Cubicin (daptomycin), a new type of
antibiotic for treating complicated skin and skin structure infections that
usually occur in hospitalized patients. Cubicin is intended to treat "staph"
and several types of "strep" infections, which can progress to
life-threatening conditions.
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01252.html
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FDA Warns Companies About Selling Unapproved Version of Accutane

FDA has sent letters to several companies warning them to stop illegal
Internet sales of unapproved, mislabeled versions of the acne drug Accutane
(isotretinoin). FDA believes that these products, which include a topical
(skin-applied) gel version of the drug, could pose serious health risks to
consumers. For example, Accutane can cause birth defects if taken by
pregnant women. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00940.html
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Milk Processors Warned to Remove 'Hormone Free' From Labels

FDA has sent warning letters to four processors of whole milk, reduced-fat
milk, and ice cream, informing them that their products are misbranded
because the labels contain the false statements "no hormones" or "hormone
free." FDA explains that all milk contains naturally occurring hormones, and
milk cannot be processed in a way that renders it hormone free.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00943.html
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Campaign to Inform Women About Risks, Benefits of Hormone Therapy

FDA has joined with two members of Congress to launch a nationwide campaign
aimed at raising awareness about recent findings on risks and benefits of
menopausal hormone therapy. Included in the campaign are a menopause and
hormone therapy fact sheet, along with a "purse guide" that provides
questions for discussion with a healthcare professional, both available
online or in printed form.
Press release:  http://www.fda.gov/bbs/topics/NEWS/2003/NEW00938.html
More information:  http://www.fda.gov/womens/menopause/
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Consumers Advised Not to Drink Teas Brewed From Star Anise Herb

Following reports linking brewed teas made with the herb star anise to
illnesses affecting about 40 persons, 15 of them infants, FDA is advising
consumers to avoid drinking those teas. Though the agency has not identified
the specific type of star anise involved in the illnesses, it issued the
advisory as an interim measure while gathering more information.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00941.html
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FDA Urges Developing Two Drugs That Can Treat Radiation Exposure

As part of its efforts to provide the public with treatments in the event of
a terrorist attack, FDA is calling for manufacturers to submit applications
for approval of two drugs that, under certain conditions, can be safe and
effective for treating internal contamination with the radioactive elements
plutonium, americium, or curium.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00944.html
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McClellan Praises House Committee Passage of Animal Drug User Fee Bill

FDA Commissioner Mark B. McClellan, M.D., has issued a statement praising
members of the House Energy and Commerce Committee for their passage of the
Animal Drug User Fee Act of 2003. As passed by the committee, the
legislation authorizes collection of fees totaling $43 million over five
years to accelerate and improve the review of new animal drugs.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00942.html
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RECALLS

The following product is being recalled for the reason shown. Go to the
linked page for more information.

Mandalay Trading Corp. Macapuno Strings (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/mandalay09_03.html
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