Food and Drug Administration--Press Releases
Sun Apr 24 04:23:42 EDT 2011
Home: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml
Feed: http://www.fda.gov/bbs/topics/news/rssPress.xml

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 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 '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 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.

FDA permits marketing of first test to help diagnose dengue fever - The U.S. Food and Drug Administration today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.

FDA clears single-use antibacterial surgical respirator - The U.S. Food and Drug Administration cleared the SpectraShield 9500 N95 surgical respirator, a device that kills 99.99 percent of three different kinds of bacteria when exposed to its outer surface.

FDA clears test for bacteria that can cause serious intestinal disease - The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI), a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases.

FDA approves Horizant to treat restless legs syndrome - On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).

FDA approves new treatment for rare form of thyroid cancer - medullary, thyroid cancer

FDA approves new device to treat brain aneurysms - The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.

FDA acts to prevent contamination problems with Triad antiseptic products - U.S. Marshals seize drug products manufactured and distributed by Wisconsin firms

FDA launches consumer-friendly Web search for consumers during recalls - Beginning today, consumers can search for food and other product recalls easier and quicker on FDA’s website than previously. The FDA Food Safety Modernization Act (FSMA) signed into law in January by President Obama called for a more consumer-friendly recall search engine. DSK

FDA proposes draft menu and vending machine labeling requirements, invites public to comment on proposals - The U.S. Food and Drug Administration today issued two proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines. The FDA invites input on the proposed regulations by visiting http://www.regulations.gov. (SY)

JOINT EPA/FDA STATEMENT: Update on Ongoing Monitoring - In response to the ongoing situation in Japan, the U.S. Environmental Protection Agency has taken steps to increase the level of nationwide monitoring of milk, precipitation, drinking water, and other potential exposure routes.

FDA Issues Statement on Makena - On February 3, 2011, the Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.

FDA Warns Consumers to Stop Using Soladek Vitamin Solution - The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D. Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.

FDA approves new treatment for a type of late-stage skin cancer - The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.