The main differences between Abilify and Abilify Maintena are how they are supplied, how they are administered, their FDA-approved uses and their costs. They both contain the active ingredient aripiprazole, an atypical antipsychotic, and are approved for the treatment of schizophrenia and bipolar diso...
Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Abilify (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deli...
Abilify (aripiprazole) is an atypical antipsychotic drug used to treat bipolar disorder and schizophrenia, which is also indicated as adjunctive treatment of major depressive disorder andTourette’s syndrome(1). Aripiprazole was approved by the U.S. Food and Drug Administration (FDA) for the treatme...
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS ANDPRECAUTIONS]. Antidepressants increased the risk of suicidal thoughts and behavior in...
As such, aripiprazole lauroxil was determined to be an active moiety not previously approved by FDA and designated as a “New Chemical Entity.” Therefore, the drug was given 5 years of market exclusivity. Postmarket Reporting There were no postmarketing requirements imposed on Alkermes for ...
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Suicidal Thoughts And Behaviors Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during treatment and when the dose is adjusted up or...
First FDA-approved2-monthLAI dose for adult patients with schizophrenia.For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating ARISTADA or ARISTADA INITIO.1,2,6 Explore the2-monthdoseSee Important Dosing Considerations ...
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either incr...
However, given the absence until recently of any drugs approved for this indication, there has been little systematic research on the pattern and predictors of MOTN awakenings or their treatment. A 4-week, double-blind, outpatient clinical trial in insomnia characterized by MOTN awakenings provides ...
Indication Treatment Arm N Patients n (%) Weight gain ≥ 7% of body weight Schizophrenia * Aripiprazole Placebo 852 379 69 (8.1) 12 (3.2) Bipolar Mania † Aripiprazole Placebo 719 598 16 (2.2) 16 (2.7) Major Depressive Disorder (Adjunctive Therapy) ‡ Aripiprazole Placebo 347 330 18...