Filed Under (Mental Disorders) by David on 31-01-2010
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Two new indications are now approved for aripiprazole (Abilify), an atypical antipsychotic agent.
Otsuka and Bristol-Myers Squibb have announced the approval of their sNDA for aripiprazole to treat positive and negative symptoms of schizophrenia in adolescents 13 to 17 years of age. Aripiprazole was first approved for the treatment of schizophrenia in adults in 2002.
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Filed Under (Mental Disorders) by David on 24-01-2010
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The FDA has approved a label change for a once-daily therapy for attentiondeficit hyperactivity disorder (ADHD). The label for lisdexamfetamine dimesylate (Vyvanse) will now include data showing significant symptom control in children six to 12 years of age from the first time point measured (1.5 hours) through 13 hours after the dose is taken.
With this approval, Vyvanse becomes the first oral ADHD drug stimulant to have 13-hour post-dose efficacy data for pediatric patients included in its labeling.
Source: Shire, June 1, 2009
Filed Under (Mental Disorders) by David on 23-01-2010
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In a new study, children and teenagers who took stimulants such as methylphenidate for attention-deficit hyper-activity disorder (AHD) appeared to be at an increased risk of sudden cardiac death. However, the FDA says the study has limitations and should not change the way the drugs such as Ritalin (Novartis) are used. Although the risk of sudden death is small, the study raises concerns about children with undiagnosed heart conditions.
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According to a new study, thousands of patients with schizophrenia might not have died if they had received the antipsychotic agent clozapine (e.g., Clozaril, Novartis).
Approved in the 1970s, clozapine was banned for about 10 years because of a rare but potentially deadly side effect: up to 2% of patients lose white blood cells while taking the drug. The drug was brought back to the market in the 1980s with warnings about its use. In most developed countries, clozapine is recommended only as a last resort if patients have already tried two other drugs but have not improved.
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