FDA rejects application for additional use of Risperdal

2/11/2009

CAMBRIDGE, Mass. The Food and Drug Administration has rejected an application from Alkermes and Johnson & Johnson for approval of an additional use of the drug Risperdal Consta (risperidone), Alkermes has announced.

The FDA said in its response that it would need additional information before approving Risperdal Consta as an adjunctive maintenance treatment to delay mood swings in patients with frequently relapsing bipolar disorder.

 Alkermes said J&J is evaluating the FDA's letter and will work with the agency to resolve the issues.

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