Teva debuts generic Abilify as FDA approves first copies

The US Food and Drug Administration yesterday approved the first generic versions of Bristol-Myers Squibb (NYSE: BMY) and Japanese drugmaker Otsuka Pharmaceutical’s (TYO: 4768) Abilify (aripiprazole), an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.

Alembic Pharmaceuticals Hetero Labs, Teva Pharmaceutical Industries and Torrent Pharmaceuticals have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms, the agency noted.

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 behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.