The drug is a generic version of Janssen’s Risperdal, which has annual US sales of $66 million.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today announced that it had obtained tentative US Food and Drug Administration (FDA) marketing approval for generic oral Risperdal in 1 mg/ml dosages. Risperdal is made by Janssen LP. Final approval is expected with the patent expires at the end of December 2007.
Upon final approval, Teva's generic Risperidone will be the AA-rated generic equivalent of Risperdal Oral Solution, used to treat schizophrenia and acute manic or mixed episodes associated with Bipolar I Disorder.
IMS data indicate that annual brand product sales in the US were $66 million for the twelve months ended June 2006. Two days ago, the FDA granted Johnson & Johnson (NYSE:JNJ) marketing approval for its version of the drug.
Teva today won a recommendation from Deutsche Bank, which included the share in its top picks in EMEA. The investment bank said that in the long term Teva would be driven by synergies from the Ivax acquisition in 2007 and new products.
Published by Globes [online], Israel business news - www.globes.co.il - on October 12, 2006
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