For the second time in recent days, regulators turned down a request from
Johnson & Johnson
to expand the approved uses for Risperdal, the drug maker's treatment for bipolar disorder.
Johnson & Johnson received a not approvable letter from the Food and Drug Administration to use Risperdal in Alzheimer's-related psychoses. The company said Thursday that it sees an unmet need for drugs that treat Alzheimer's-related psychoses, and its research and development group "is evaluating the FDA's letter and will determine appropriate next steps."
the FDA blocked another attempt at expanding labeling for the drug, when the New Brunswick, N.J., company was denied a bid to get Risperdal cleared as a treatment for autism.
Although doctors can prescribe drugs for what's called off-label uses, FDA approval is required for pharmaceutical companies to market their drugs for a specific purpose.
Shares of Johnson & Johnson were recently up 3 cents to $67.50.