FDA lifts some restrictions on diabetes drug AvandiaNovember 26th 2013
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 approves first adjuvanted vaccine for prevention of H5N1 avian influenza for National StockpileNovember 25th 2013
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.
Label, packaging changes requested for some OTC topical antiseptic productsNovember 22nd 2013
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 approves first generic versions of Aciphex delayed-release tablets to treat GERDNovember 12th 2013
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).
Data from HCV clinical trials presented at Liver Meeting in D.C.November 8th 2013
New data evaluating the investigational protease inhibitor faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV), studied in genotype 1 (GT1) patients with hepatitis C (HCV), were presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting, in Washington, DC.
Anti-seizure drug gets boxed warning of potential vision lossNovember 5th 2013
FDA has approved a new boxed warning for the anti-seizure drug ezogabine (Potiga) because of the potential risk of vision loss, retinal abnormalities, as well as skin, nail, mucous membrane, and sclera discoloration. The agency recommends that ezogabine use be limited to individuals who have not responded to alternative therapies for seizure control, and when the benefits of treatment are greater than the risks.
Under breakthrough therapy designation, FDA approves chronic lymphocytic leukemia drugNovember 1st 2013
FDA has approved obinutuzumab (Gazyva, Genentech, a member of the Roche Group), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).