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12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA,(methylphenidate transdermal system)

in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth monitoring is advised during prolonged treatment.

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

The most common adverse events reported in clinical studies of VYVANSE included: pediatric - loss of appetite, insomnia, abdominal pain, and irritability. The most common adverse events reported in clinical studies of ADDERALL XR included: pediatric - loss of appetite, insomnia, abdominal pain, and emotional lability; adolescent - loss of appetite, insomnia, abdominal pain, and weight loss; adult - dry mouth, loss of appetite, insomnia, headache, and weight loss.

About SPD465 (triple-bead mixed amphetamine salts):

SPD465 recently received an approvable letter from U.S. Food and Drug Administration (FDA) for the treatment of ADHD in adults. SPD465, a single entity, mixed amphetamine salt formulation was studied to determine if it provides symptom control for up to 16 hours in adults with ADHD. The most commonly reported treatment-emergent adverse events were decreased appetite, insomnia, dry mouth, headache, upper abdominal pain and anorexia.

About SPD503 (guanfacine HCl extended release):

SPD503 is currently under review with FDA for the treatment of ADHD in children aged 6 to 17 years. SPD503
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