Yesterday, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized breaded seafood products that have been repacked by Fellerson, Inc., a firm that does business as K&S Wholesale Meats, for Soderholm Wholesale Foods, both of Sun Prairie, Wis., because the products are adulterated.
Category Archives: Drug Safety Information Podcasts
FDA approves Zytiga for late-stage prostate cancer
The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
FDA seeks permanent injunction against Pennsylvania dairy
The Justice Department, at the request of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Daniel L. Allgyer, owner of the Rainbow Acres Farm, in Kinzers, Pa., for distributing unpasteurized (or “raw”) milk for human consumption in interstate commerce.
FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers
The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.
FDA ‘Strategic Priorities 2011 – 2015’ Now Available
The U.S. Food and Drug Administration today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015.
FDA warns companies to stop making MRSA claims for over-the-counter products
The U.S. Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA).
FDA approves Rituxan to treat two rare disorders
The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).
FDA approves new medical device for form of brain cancer
The U.S. Food and Drug Administration recently approved the NovoTTF-100A System, a new device to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy.
FDA approves Actemra to treat rare form of juvenile arthritis
The U.S. Food and Drug Administration today approved Actemra (tocilizumab), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children ages 2 years and older.
FDA approves new treatment for large brain aneurysms
The U.S. Food and Drug Administration has approved the cPAX Aneurysm Treatment System for surgery on brain aneurysms that are difficult to manage because of their size and shape.