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US FDA nod for generics of Abilify


To market generic aripiprazole in multiple strengths and dosage forms to treat mental disorders

The US Food and Drug Administration has approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

“Having access to treatments is important for patients with long-term health conditions,” said John Peters, Acting Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug,” he added.

Schizophrenia is a chronic, severe and disabling brain disorder. Symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behaviour and a decreased need for sleep.

All atypical antipsychotics contain a boxed warning alerting healthcare 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.

EP News BureauMumbai

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