Aripiprazole (marketed as Abilify, Abilify Discmelt) is an atypical antipsychotic medication approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. 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, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that widespread generic erosion of branded atypical antipsychotics will cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to approximately $5 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
Bristol-Myers Squibb Company today reported strong sales and earnings growth for the third quarter 2009.
A new treatment option for Canadians with schizophrenia, ABILIFY(TM) (aripiprazole), is now available in Canada. For those living with this lifelong disease who may be struggling with a treatment that doesn't work for them or with side effects that are difficult to tolerate, ABILIFY offers efficacy and good safety and tolerability with limited impact on weight, blood sugar and lipids - significant clinical benefits that may help patients stay on treatment longer.
St. Petersburg Times recently examined how since the Florida Medicaid program last year began requiring physicians to receive approval before prescribing antipsychotic drugs to children younger than age six, the number of prescriptions for children in that age group has dropped by nearly 75%, according to new data from the Florida Agency for Health Care Administration.
Health officials in the U.S. are warning doctors that prescribing certain psychiatric drugs to elderly people suffering from dementia can increase their risk of death.
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old).
An anti-psychotic drug already approved in the U.S. to treat adults and adolescents with schizophrenia may soon be available for youngsters age 10 to 17 years of age suffering from bipolar disorder.
The number of visits to a doctor's office that resulted in a diagnosis of bipolar disorder in children and adolescents has increased by 40 times over the last decade, reported researchers funded in part by the National Institutes of Health (NIH).
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced two newly available options of Abilify (aripiprazole) -- a 2 mg tablet strength and a nonrefrigerated oral solution (1 mg/mL).
The Food and Drug Administration (FDA) has issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label”) use of certain drugs called “atypical antipsychotic drugs.”
The Food and Drug Administration (FDA) has issued a public health advisory to health care providers, patients, and caregivers to alert them to new safety information about the use of certain unapproved or off label drugs which come under the category of “atypical antipsychotic drugs.”
Bristol-Myers Squibb and Otsuka Pharmaceutical have announced that the U.S. Food and Drug Administration (FDA) has approved Abilify (aripiprazole) for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.
This newly approved or tentatively approved drug listing from the FDA is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed.