FDA has eased restrictions on patient access to the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). The agency made its determination after an FDA Advisory Committee reviewed the drug in June 2013 and voted to lift its restrictions, and new information was released indicating that the drug carries no heightened cardiovascular risk.
FDA approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people aged 18 years and older who are at increased risk of exposure to the H5N1 influenza virus.
FDA has requested label and packaging changes for certain over-the-counter (OTC) topical antiseptic products to decrease the risk of infections from these products, which in rare cases have resulted in deaths.
FDA has approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (aged 12 years and up).