FDA has approved tocilizumab (Actemra), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis in children 2 years of age and older.
The number of people treated in U.S. hospitals for illnesses and injuries from taking medicines increased 52%—from 1.2 million to 1.9 million—between 2004 and 2008, according to an April 2011 report from the Agency for Healthcare Research and Quality.
FDA has approved peginterferon alfa-2b (Sylatron, Merck) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
FDA said it wouldn't take action against compounding pharmacies that continue to supply 17 alpha hydroxyprogesterone caproate.
FDA recently approved vandetanib to treat patients with late-stage (metastic) medullary thyroid cancer who are ineligible for surgery and have a disease that is growing and causing symptoms.
FDA issued drug safety communications about a serious adverse effect associated with the use of over-the-counter benzocaine gels, sprays, and liquids applied to the throat and gums to reduce pain.
FDA has approved gabapentin enacarbil (Horizant Extended-Release Tablets, GlaxoSmithKline and XenoPort), a once-daily treatment for moderate-to-severe restless legs syndrome, also known as Ekbom disease. It is the first medication in its class to be approved for this condition.
FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.
The U.S. House of Representatives requested in a letter to CMS that the agency consider the delay of a provision in a recently proposed rule requiring certain prescriptions to be dispensed in 7 days or less increments.