The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
Category Archives: Food & Drug Recalls
FDA approves vaccine for use after known or suspected anthrax exposure
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
FDA approves Opdivo to treat advanced form of kidney cancer
The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.
Casey’s Bakery Inc. Issues Allergy Alert On Undeclared Peanuts in Snickers 8×8 Cake
Casey’s Bakery Inc. of Sioux Center, Iowa is voluntarily recalling all Snickers 8×8 cakes produced prior November 14, 2015, because the cakes contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA approves Ninlaro, new oral medication to treat multiple myeloma
Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.
Fit Firm and Fabulous Issues Voluntary Nationwide Recall of Ultimate Herbal Slimcaps Due to the Presence of Undeclared Sibutramine
Fit Firm and Fabulous is voluntarily recalling lots 05/02/2015 to 05/01/2017 of Ultimate Herbal Slimcap capsules, to the consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons.
FDA takes several actions involving genetically engineered plants and animals for food
Based on sound science and a comprehensive review, the U.S. Food and Drug Administration (FDA) is taking several important steps today regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants.
FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.
Wegmans Food Markets Issues Allergy Alert on Undeclared Tree Nuts (Cashews and Almonds) in Wegmans Italian Classics Butternut Squash Ravioli, 9 oz.
Wegmans Food Markets, Inc. is recalling Wegmans Italian Classics Butternut Squash Ravioli, 9 oz. (UPC #77890 36434), because the product may contain undeclared cashews and almonds. People who have an allergy or severe sensitivity to cashews or almonds run the risk of serious or life-threatening allergic reaction if they consume this product.
Ashdon Farms Issues Allergy Alert on Honey Mustard Pretzel Mix and Honey Mustard Mix
Ashdon Farms, Waukesha, WI 53188 is alerting consumers that Honey Mustard Pretzel Mix sold under the Girl Scouts of the USA brand and Honey Mustard Mix sold under the Ashdon Farms brand distributed to consumers on or before November 15, 2015 are being recalled because milk is not declared in the contains statement on the label.