The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.
Category Archives: Drug Recalls & Safety Notices
FDA: Michigan heart-lung bypass machine manufacturer enters into consent decree
The U.S. Food and Drug Administration today announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction.
FDA, EMA announce pilot for parallel assessment of Quality by Design applications
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.
FDA approves imaging agent for central nervous system scans
The U.S. Food and Drug Administration today approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.
Maryland sprout processor enters into consent decree with the FDA
The Food and Drug Administration announced today that Vegi-Pak Farm LLC of Mt. Airy, Md., and its president, Sun Ja Lee, and general manager, Brian W. Lee, signed a consent decree recently prohibiting them from processing, holding and distributing bean sprouts due to their failure to comply with federal food safety laws.
Vegi-Pak Farm grows, processes, packages and distributes ready-to-eat soybean sprouts and holds and distributes tofu and mung bean spouts. The products are sold to markets in Maryland, Virginia and Washington, D.C. DSK
FDA approves device to maintain blood flow during artery bypass brain surgery
The U.S. Food and Drug Administration today approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.
FDA, Justice Department take action against McNeil-PPC Inc.
The U.S. Food and Drug Administration announced today that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.
FDA approves Benlysta to treat lupus
The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
FDA: Risk of oral birth defects in children born to mothers taking topiramate
New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.
FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis
The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).