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.
Category Archives: Drug Recalls & Safety Notices
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.
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 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 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.