Clean Energy Systems

December 1, 2003

______________________________________________________________

New Drug OK'd for Treating Advanced Prostate Cancer

FDA has approved the marketing of Plenaxis (abarelix), a drug for advanced
prostate cancer for patients who have no alternative therapy. The drug will
be marketed under a voluntary risk management program agreed to and
administered by the sponsor that will restrict the use of Plenaxis to
patients with advanced prostate cancer who have no alternative therapy
because of an increased risk of serious and potentially life-threatening
allergic reactions associated with its use.

http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01268.html

______________________________________________________________

FDA Updates Adverse Event Information for Cordis Coronary Stent

FDA has updated the notice it sent to physicians in October about reports of
clotting and hypersensitivity in patients receiving the Cordis Cypher
Coronary Stent. The stent is a drug-treated mesh cylinder implanted in
patients undergoing angioplasty to open clogged coronary arteries. After a
review of clinical studies, the agency says clotting is within the expected
rate, and hypersensitivity problems tend to be minor. FDA emphasizes that
the Cordis stent is safe and effective when used according to the label.

Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01267.html

More information: http://www.fda.gov/cdrh/safety/cypher2.html

______________________________________________________________

FDA Calls Appeals Court Denial to Rx Depot Motion a 'Clear Signal'

FDA says that a recent Circuit Court of Appeals ruling to deny foreign drug
importer Rx Depot a motion to stay an earlier District Court's ruling
shutting down the firm is a "clear signal" that other businesses importing
medicines illegally "will not be allowed to threaten the public health."

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00983.html

______________________________________________________________

FDA Advises Oregon Consumers about Possible
Salmonella Contamination of Raw Sprouts

Following a reported six cases of Salmonella in Oregon possibly linked to
raw sprouts, FDA is repeating its earlier advice about eating raw sprouts.
People at high risk of developing foodborne illness, including children, the
elderly, and those with weakened immune systems, should not eat raw sprouts.
Others who wish to reduce their risk of illness should also avoid raw
sprouts.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00984.html

______________________________________________________________

Contaminated Food Seized at Washington, D.C., Warehouse

At FDA's request, U.S. marshals have seized scores of containers of food at
Washington, D.C.-based Phoenix Enterprises, after the company repeatedly
ignored warnings from the agency that the company needed to take steps to
avoid rodent infestation and contamination of stored food products. The
company distributes dried oriental noodles and other dried food products.

http://www.fda.gov/bbs/topics/news/2003/doj112803.html

______________________________________________________________

FDA Commissioner Praises Senate Action on Public Health Measures

FDA Commissioner Mark B. McClellan, M.D., has issued a statement thanking
several U.S. senators for their leadership in recent actions on public
health bills. McClellan applauded Senate committee work related to food
labeling for consumers with allergies, new animal therapies, mammography
standards, and medical device user fees.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00982.html

______________________________________________________________

RECALLS/MARKET WITHDRAWALS

The following products are being recalled or withdrawn for the reasons
shown. Go to the linked page for more information.

Apio Fresh, LLC Green Onions (possible link to hepatitis A)

Harmony Farms Alfalfa Sprouts; several varieties and sizes (possible
Salmonella contamination)

Kien Import Corp. Evergreen Melon Candy (undeclared sulfites)

Malatya Dried Apricots (undeclared sulfites)

KB Specialty Foods Deli Chef Sour Cream & Cheese Macaroni Salad (possible
Listeria monocytogenes contamination)

For an archive of FDA-related recalls and safety alerts from the last 60
days, click here:

______________________________________________________________

RECENT TESTIMONY

FDA Associate Commissioner for Regulatory Affairs John M. Taylor III, before
the Senate Committee on Commerce, Science and Transportation (Nov. 20)
http://www.fda.gov/ola/2003/rxdrugs1120.html

FDA Deputy Commissioner Lester M. Crawford, D.V.M., before the Senate
Committee on Governmental Affairs (Nov. 19)
http://www.fda.gov/ola/2003/counterterrorism1119.html

For an archive of testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html