Shares in India's Torrent Pharmaceuticals jumped more than 4% in Mumbai on Wednesday, and Alembic Pharmaceuticals rose nearly 6% after they were among four winners of U.S. FDA approval for the sale of the first generic versions of Abilify, an antipsychotic from Japan's Otsuka Pharmaceuticals and Bristol-Myers Squibb ($BMY) for treating schizophrenia and bipolar disorder.
India's Torrent Pharmaceuticals, Alembic Pharmaceuticals, Hetero Drugs and Israel's Teva Pharmaceuticals ($TEVA) were the four generic drug makers that received regulatory approval to sell the drug.
But the FDA pointed out it comes with a warning about an increased risk of death associated with the off-label use for behavioral problems tied to dementia. The agency also pointed out there are no drugs in the class approved for treating dementia-related psychosis.
Otsuka and Bristol-Myers Squibb collected $5.5 billion in Abilify sales last year.
- here's the FDA release