April 16, 2013
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to […]
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April 16, 2013
U.S. Marshals have seized food products at a Ridgewood, N.Y. warehouse that manufactures and distributes kosher food products, after investigators from the U.S. Food and Drug Administration found widespread rodent infestation in the facility.
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April 10, 2013
The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and […]
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April 8, 2013
The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
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March 30, 2013
The U.S. Food and Drug Administration today approved Invokana (canaglifozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
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March 28, 2013
The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
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March 22, 2013
The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
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March 22, 2013
The U.S. Food and Drug Administration (FDA) today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.
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March 22, 2013
The U.S. Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin. The product is derived from horse plasma and contains a mixture of antibody fragments that neutralize all of […]
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March 21, 2013
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, Ga. The recall of all sterile products is due to the FDA’s preliminary findings of practices at the site which raise […]
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March 20, 2013
The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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March 18, 2013
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J, a specialty pharmacy licensed by the State of New Jersey. The recall was announced after health care providers at a hospital […]
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March 18, 2013
Pro-Amino International Inc., of Saint-Eustache, Quebec, Canada, is recalling the ProtiDiet High Protein Chocolate Dream Bars. The recalled product may contain Salmonella.
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March 13, 2013
The U.S. Food and Drug Administration announced that a federal judge has approved a consent decree of permanent injunction against Butterfly Bakery Inc., a bakery based in Clifton, New Jersey, and its president, Brenda Isaac, for unlawfully distributing misbranded food products, such as muffins and snack cakes.
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March 13, 2013
The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
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March 9, 2013
The U.S. Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).
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February 27, 2013
The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
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February 26, 2013
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and that no longer respond to other FDA-approved treatments for this disease.
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February 25, 2013
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill., due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat […]
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