First Generic Abilify Approved

[IceWizard]

(HealthDay News)-- The first generic versions of the atypical antipsychotic drug Abilify (aripiprazole) have been approved by the U.S. Food and Drug Administration to treat schizophrenia or bipolar disorder.

License to produce the drug in multiple
strengths was approved for Alembic
Pharmaceuticals, Hetero Labs, Teva
Pharmaceuticals, and Torrent Pharmaceuticals, the agency said in a news release.

Bipolar disorder, also known as manic
depression or manic-depressive illness, is a
brain disorder that causes unusual moods and
activities, affecting the ability to carry out day-to-day tasks.

Symptoms typically include alternating periods of depression (lows) and increased activity and restlessness (highs).

Schizophrenia, another brain disorder, affects
about 1 percent of Americans. Symptoms
typically begin in people younger than 30, and
include hearing voices, believing other people
are controlling their minds or actions, and being suspicious and withdrawn.

As with other atypical antipsychotic drugs,
generic Abilify's label will contain the FDA's most stringent boxed warning that the medication poses an increased risk of death among older people with dementia-related psychosis.

The label also warns of an increased risk of suicidal thinking and behavior among children, teens and young adults.

The most common side effects of the drug are
nausea, vomiting, constipation, headache,
dizziness, body twitching, anxiety, insomnia and restlessness.

The FDA release included a statement that
approved generic drugs are produced to the
same quality standards as their brand-name
counterparts.


Visit the FDA to learn more about this approval