The FDA has approved sunitinib (Sutent, Pfizer), a targeted treatment for patients with advanced kidney cancer and gastrointestinal stromal tumors (GISTs), a rare stomach cancer. This action marks the first time that the agency has approved an oncology product for two indications simultaneously.
Sunitinib, a tyrosine kinase inhibitor, deprives tumor cells of blood and nutrients needed [...]
The FDA has approved conivaptan HCl injection (YM087, Vaprisol, Astellas Pharma), an arginine vasopressin (AVP) antagonist for hospitalized patients with euvolemic hyponatremia.
Euvolemic hyponatremia is a potentially life-threatening condition that occurs when the body’s blood sodium level falls significantly below normal. Hyponatremia affects almost 4% of hospitalized patients in the U.S. each year. Although many patients [...]
Can the window of time for giving tissue plasminogen activator (tPA) to patients with ischemic stroke safely be opened wider, from the standard three hours to six hours? Researchers from university hospitals in Hamburg, Heidelberg, and Cologne, Germany, suggest that instead of a one-size-fits-all approach based on clock time, it might be possible to tailor [...]
The FDA’s Psychopharmacologic Drugs Advisory Committee has voted not to recommend approval of modafinil tablets (Sparlon, Cephalon), an investi-gational medication for children and adolescents with ADHD. Cephalon had received an approvable letter from the FDA in October 2005. Modafinil was deemed effective for its intended use, but more safety data were needed.
Sparlon is a new [...]
The FDA has approved the molecular entity rasagiline (Agilect, Azilect, Teva Pharmaceuticals, Israel) for the treatment of Parkinson’s disease. The drug is a monoamine oxidase type-B inhibitor that blocks the breakdown of dopamine. Dopamine sends information to the parts of the brain that control movement and coordination.
Parkinson’s disease is caused by the destruction of the [...]
Decitabine injection (Dacogen, MGI Pharma, Inc./SuperGen, Inc.) has been approved by the U.S. Food and Drug Administration (FDA) for patients with myelodysplastic syndromes (MDS). MDS comprises a group of bone marrow diseases characterized by the production of poorly functioning and immature blood cells. Over time, MDS can progress to acute leukemia.
A phase 3 clinical trial [...]
The FDA and the Institute for Safe Medication Practices (ISMP) have launched a nationwide campaign aimed at reducing the number of common sources of medication errors caused by the use of unclear medical abbreviations, symbols, and dose designations, which have often resulted in harm to patients. According to the Institute of Medicine (IOM) of the [...]
