US regulators have approved the first generic versions of Abilify (aripiprazole), sold in the US by Bristol-Myers Squibb, for the treatment of schizophrenia and bipolar disorder.
Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals have all been issued a green light by the US Food and Drug Administration to market their copycats in multiple strengths and dosage forms.
All atypical antipsychotics contain a Boxed Warning 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, as well an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults taking antidepressants.
As such, patients should be monitored for worsening and emergence of suicidal thoughts and behaviours, and any aripiprazole product must be dispensed with a patient Medication Guide describing the drug’s uses and risks, the FDA stressed.
B-MS booked Abilify sales $554 million for the first quarter of this year, inching up 3% from the year-ago period. Overall sales were up 6% at $3.8 billion, while earnings came in at $1.2 billion, compared to $937 million booked for the first quarter of 2014.