The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Absence of this enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States.
Category Archives: Food Safety News
Illegal prescription drug sellers arraigned on charges for smuggling illicit cancer drugs into the United States
Two individuals today were arraigned for charges that they, among other things, smuggled adulterated and misbranded prescription cancer treatments from Turkey and other countries into the United States and conspired to defraud the United States and the U.S. Food and Drug Administration. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States.
FDA approves Imbruvica to treat chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
Mars Foodservices US Recalls Infused Rice Products Sold For Wholesale Distribution –UNCLE BEN’S® Retail Grocery Products Not Affected–
Mars Foodservices US is voluntarily recalling Foodservices UNCLE BEN’S® INFUSED® Rice products, which are only sold in 5 lbs and 25 lbs bags. UNCLE BEN’S® Brand Ready to Heat, Boxed, Bag or Cup Products available in supermarkets and other retail outlets are not involved.
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FDA warns against using Uncle Ben’s Infused Rice
The FDA, the Centers for Disease Control and Prevention (CDC), and state and local officials have been investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags.
Natural Grocers by Vitamin Cottage Issues Allergy Alert on Undeclared Peanuts in Dark Chocolate Almonds
Colorado – Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado based natural grocery chain, is recalling one lot of six ounce packages of Natural Grocers brand Dark Chocolate Almonds with the Julian packed-on date 13-351 because some bags in this lot may contain dark chocolate covered peanuts which are not declared on the label. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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Big Red Tomato Packers, LLC Voluntarily Recalls Fresh Tomatoes Due to Possible Risk of Contamination from Salmonella
Big Red Tomato Packers, LLC of Fort Pierce, FL is voluntarily issuing a limited recall of 790 – 20 and 25 lb. boxes of fresh tomatoes of lot 1106, because they may have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems.
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Updated FDA requirements for infant formula will maintain high-quality standards and help ensure healthy growth of infants
Today, the U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
FDA Commissioner Hamburg travels to India
Today, the U.S. Food and Drug Administration announced that Commissioner Margaret A. Hamburg, M.D. will travel February 10-18 to India to further strengthen cooperation between the FDA and its Indian regulatory counterparts.
FDA launches its first national public education campaign to prevent, reduce youth tobacco use
The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent youth tobacco use and reduce the number of kids ages 12 to 17 who become regular smokers. ‘The Real Cost’ campaign is the FDA’s first of several planned tobacco education campaigns using the new authority granted under the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.