(Reuters) - The U.S. Food and Drug Administration said it approved the first copycat versions of Otsuka Pharmaceutical Co Ltd’s antipsychotic drug, Abilify.
The FDA said on Tuesday that it had granted approval for generic versions of Abilify from four companies, including Teva Pharmaceutical Industries Ltd, to treat mental illnesses such as bipolar disorder and schizophrenia. (1.usa.gov/1EO2DvW)
Abilify has an orphan drug designation for the treatment of Tourette’s syndrome, a nervous system disorder, in children.
The drug, which is also approved to treat schizophrenia and bipolar disorder, went off patent protection for these indications this month.
Japanese drugmaker Otsuka bought Avanir Pharmaceuticals Inc in December for $3.5 billion to expand its offering of neurological products before Abilify went off patent protection.
Abilify, which is sold by Bristol-Myers Squibb Co in the United States, brought in sales of $554 million in the first quarter.
(This version of the story adds details)
Reporting by Vidya L Nathan in Bengaluru; Editing by Saumyadeb Chakrabarty and Kirti Pandey