FDA Actions

The FDA has approved asenapine (Saphris®) for the treatment of schizophrenia and bipolar I disorder in adults. The drug is approved for first-line treatment of both conditions. Schering-Plough provided the agency with safety data in 4500 patients, some of whom were treated for more than 2 years. Like other antipsychotics, asenapine will carry a warning regarding increased mortality in elderly patients with dementia-related psychosis. The drug is expected to be available in the fourth quarter of 2009.

The FDA has lowered the approved age limit for levocetirizine (Xyzal®) to 6 months for children with chronic hives and perennial allergic rhinitis and 2 years for children with seasonal allergic rhinitis. Previously the drug had been approved for children 6 years and older. Levocetirizine is marketed by UCB and Sanofi Aventis.