The US drug regulator, US Food & Drug Administration (FDA) has approved the first generic versions of Abilify (compound aripiprazole) used in the treatment of schizophrenia and bipolar disorders.
Alembic Pharmaceuticals, Hetero Labs, and Torrent Pharmaceuticals from India and Teva Pharmaceuticals have received US FDA approval to market generic aripiprazole in multiple strengths and dosage forms, a US FDA statement said.
Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorders. Abilify, developed by Otsuka Pharmaceutical of Japan, is marketed by Otsuka jointly with Bristol-Myers Squibb in the USA. It had annual sales of around US $ 7.8 billion in the USA according to IMS data of December 2014.
Schizophrenia is a chronic, severe and disabling brain disorder and about one per cent of Americans have this illness. 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.
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
