FDA Actions in Brief August 2012
September 1st 2012Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)
Belviq (Lorcaserin): A 5-HT2C receptor agonist indicated to treat certain overweight or obese adults
September 1st 2012New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.
Teduglutide: A novel recombinant analog of human glucagon-like peptide-2 for short bowel syndrome
September 1st 2012Teduglutide is a recombinant analog of human glucagon-like peptide-2 that is awaiting FDA approval for the treatment of short bowel syndrome (SBS) as a once-daily subcutaneous injection.
FDA approves once-daily phentermine and topiramate extended-release for weight management
July 20th 2012FDA has approved once-daily phentermine and topiramate extended-release (Qsymia, Vivus) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater, or 27 or greater in the presence of at least 1 weight-related comorbidity.
FDA: Label change for single IV dose of ondansetron
July 20th 2012FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
Study: Older patients often ignore prescription warning labels
July 6th 2012Brightly colored prescription warning labels applied by pharmacies fail to adequately capture the attention of older patients, suggesting that current labeling standards should be reconsidered to make them more effective, according to a study published online June 14 in PLoS ONE.