MONDAY, May 18, 2009 (HealthDay News) -- The Janssen Pharmaceuticals drug Risperdal Consta (risperidone) has been approved by the U.S. Food and Drug Administration for people with Bipolar 1 disorder, the drug maker said Monday.
Risperdal Consta is the long-acting version of Risperdal, which was first FDA-approved more than a decade ago and is now sanctioned for Bipolar 1, schizophrenia and autism.
Type 1 bipolar disorder involves at least one manic episode, with or without a major depressive episode.
Approval of Risperdal Consta for Bipolar 1 was granted as a single therapy, or in combination with lithium or valproate, Janssen said in a news release.
As with similar antipsychotic drugs, the packaging for Risperdal Consta includes a warning that the drug is not approved for elderly people with dementia-related psychosis, and could increase their risk of death.
The FDA has more about this drug's approval history.