FDA delays expanded indication for J&J's Risperdal

Johnson & Johnson announced Tuesday evening that the FDA has asked for additional information before granting a new indication for Risperdal Consta. The pharma giant has asked the agency for approval to market the long-acting injection for patients with bipolar disorder who experience relapse frequently. According to J&J's statement, the FDA has requested the company address several questions, but has not asked for additional clinical trials.

The only approved long-acting atypical antipsychotic, Risperdal Consta is currently approved as a twice monthly treatment for schizophrenia. Risperdal is given in a pill form and approved to treat schizophrenia and bipolar disorder in adults, for irritability associated with autism in kids and in adolescents.

As you know, J&J lost its patent for Risperdal last year and Teva took no time to begin shipping its generic version. The branded version of the drug brought J&J $2.5 billion--6 percent of company-wide sales--in 2007. So it's no surprise that the company opted to ink a deal for an authorized generic version of the Risperdal. Once a top-seller for the company, U.S. Risperdal sales dropped 84 percent in 2008. On the other hand, Risperdal Consta sales rose 8 percent to $117 million. 

- view the Johnson & Johnson release
[1]- read The Motley Fool's take [2]

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FDA holds back on J&J schizophrenia drug [4]
J&J fights Teva with generic Risperdal [5]
Doc lobbied J&J for Risperdal-promo institute [6]
Risperdal OK'd for children [7] (Aug 2007)