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Indian pharma companies received US FDA marketing nod for generic aripiprazole

 

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Three Indian pharmaceutical companies, namely Alembic Pharmaceuticals, Hetero Labs and Torrent Pharmaceuticals have get the US Food and Drug Administration (FDA) approval for generic versions of Abilify (aripiprazole). Aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.   Teva Pharmaceuticals has also get  similar approval.

 

Schizophrenia is a mental disorder that generally appears in late adolescence or early adulthood - however, it can emerge at any time in life. It is one of many brain diseases that may include delusions, loss of personality (flat affect), confusion, agitation, social withdrawal, psychosis, and bizarre behaviour.  About one per cent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age.

Bipolar disorder is a mental illness marked by extreme shifts in mood ranging from a manic to a depressive state. Bipolar disorder is also called bipolar disease or manic depression. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

All atypical antipsychotics contain a boxed warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioural problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis. Aripiprazole’s boxed warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

In the clinical trials, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.


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