The company said it received a "not approvable" letter from the Food and Drug Administration (search), which it will review to determine the appropriate next step.
The announcement came as the company kicked off its first big meeting with analysts in four years to review its product pipeline.
Risperdal is one of J&J's biggest products, with annual sales of about $3 billion. But it faces competition from an array of other antipsychotics, including Eli Lilly and Co.'s (LLY) Zyprexa, AstraZeneca Plc's Seroquel, Pfizer Inc.'s (PFE) Geodon and Bristol-Myers Squibb Co.'s (BMY) Abilify.
To boost their market share, the companies each are seeking to win approval for additional indications for their drugs. Many of the drugs, including Risperdal, are also approved as a treatment for bipolar disorder, also known as manic depression (search).