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Oct15
FDA Grants Tentative Approval to Teva Pharmaceutical's Generic Risperdal
The U.S. Food and Drug Administration has granted tentative approval for the Abbreviated New Drug Application submitted by Teva Pharmaceuticals (TEVA) to market its generic version of Risperdal® (Risperidone) Oral Solution, 1 mg/mL. Final approval is expected on December 29, 2007, upon expiry of patent currently held by Janssen.

Risperdal is a drug indicated for the treatment of bipolar mania and schizophrenia, and is FDA approved for the treament of irritability associated with autism.

Source: Teva

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