The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
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FDA takes significant steps to address antimicrobial resistance
The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
FDA approves Sovaldi for chronic hepatitis C
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Solvadi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
FDA approves first drug treatment for Peyronie’s disease
The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
FDA reaches $1.25 million settlement with Advanced Sterilization Products and company executives
The U.S. Food and Drug Administration has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP), a division of Ethicon Inc., a Johnson & Johnson company, and two of ASP’s executives alleging that ASP manufactured and distributed adulterated and misbranded sterilization monitoring products.
Cargill Conducts Voluntary Recall of Select Nutrena® NatureWise® Meatbird and Chick Starter Feed
Cargill’s animal nutrition business today announced a voluntary recall of two of its Nutrena NatureWise poultry feeds due to incorrect levels of calcium. The affected products were manufactured at Cargill’s facilities in Flora, Ill., Oklahoma City, Okla., Abilene, Texas, and Mineola, Texas, between May 1, 2013 and Nov. 21, 2013.
FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
Huxtable’s Kitchen Issues Voluntary Allergy Alert on Undeclared Allergens in Butternut Squash & Creamed Spinach Gratin
Huxtable’s Kitchen Inc. of Vernon, California is voluntarily recalling one specific lot of Trader Joe’s Butternut Squash & Creamed Spinach Gratin (SKU 96541) sold in the refrigerated section with “Use By 12/13/13” date, because it may not list wheat and egg in the ingredients. People who have an allergy or severe sensitivity to wheat and egg run the risk of serious or life-threatening allergic reaction if they consume this product.
IQ Formulations Issues a Voluntary Recall of HYDRAVAX Dietary Supplement Due to Possible Undeclared Ingredient
IQ Formulations, of Sunrise, Florida is initiating a precautionary and proactive recall of all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of HYDRAVAX (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient – a diuretic.
FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination
A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S. Food and Drug Administration (FDA) and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by the FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.