Food :: Calls for a new food safety regulatory agency follow spinach tragedy

The recent contamination of spinach with E. coli bacteria is fostering renewed calls for a single, independent federal food safety agency that would regulate animal and plant production in an integrated way, according to an article scheduled for the Dec. 11 issue of the ACS? weekly news magazine, Chemical & Engineering News (C&EN).

Surgery :: Revised Labeling for Trasylol, Aprotinin Injection

The U.S. Food and Drug Administration (FDA) today approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations. Trasylol is given to patients before heart surgery to reduce bleeding and the need for blood transfusions. Trasylol is marketed by Bayer Pharmaceuticals Corporation, Leverkusen, Germany.

Rheumatoid Arthritis :: Pfizer’s Celebrex treats Juvenile Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) today approved Celebrex (celecoxib) for a new use ? the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older. Today’s approval follows the November 29 meeting of FDA’s Arthritis Advisory Committee, in which the committee voted 15 to 1 in favor of approval of this product.

FDA Approves Drug to Treat Cyanide Poisoning – Cyanokit

The Food and Drug Administration (FDA) today approved Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning. The approval, which is based on evidence of the drug’s effectiveness when tested in animals, improves the nation’s ability to respond to emergencies, including a potential attack by terrorists.

Taco Bell :: E. coli O157:H7 Outbreak at Taco Bell Restaurants Likely Over

Today, the U.S. Centers of Disease Control and Prevention (CDC) stated that the E. coli O157:H7 outbreak linked to Taco Bell restaurants in Northeastern states appears to be over. However, additional cases from the outbreak period could still be identified. Based on a number of factors, iceberg lettuce is considered overall to be the single most likely source of the outbreak at this time. The Food and Drug Administration (FDA) continues to narrow its investigation by focusing its efforts on finding the sources of shredded iceberg lettuce served at the restaurants.

Diabetes :: Alert on Counterfeit One Touch Blood Glucose Test Strips

The U.S. Food and Drug Administration (FDA) is providing an update to its notifications on October 13, and October 23, 2006, alerting the public to counterfeit blood glucose test strips being sold in the US for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today?s update includes an additional lot number that is being distributed, along with a description of how to identify the new lot.

Depression :: Anchen’s Bupropion Extended-Release Tablets for major depressive disorder patients

The U. S. Food and Drug Administration (FDA) today approved the first generic version of Wellbutrin XL (Bupropion hydrochloride) Extended-Release Tablets, which are indicated for the treatment of major depressive disorder (MDD). The approval is an important step in the agency’s effort to increase the availability of lower-cost generic medications. In 2005, Wellbutrin XL was the 21st highest-selling brand-name drug in the United States, with sales totaling $1,326,323,000 as reported in the online magazine Drug Topics.

Taco Bell :: FDA Narrows Investigation of E. Coli O157:H7 Outbreak at Taco Bell Restaurants

The Food and Drug Administration (FDA) today narrowed its investigation of an outbreak of E. coli O157:H7 infections linked to Taco Bell restaurants in Northeastern states by focusing its efforts on finding the sources of shredded lettuce served at the stores. This new focus is based on the fact that three items — shredded lettuce, cheddar cheese and cooked ground beef — were implicated in a study conducted by the U.S. Centers of Disease Control and Prevention (CDC) as the items most likely to have been the vehicles of pathogen (disease-causing agent) transmission in this outbreak. Based on a number of other factors, as well as food processing techniques used for cheese (pasteurization) and ground beef (cooking), lettuce is considered overall to be the single most likely source of the outbreak at this time.

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