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Teva gains FDA approval for generic Risperdal

The US FDA has granted final approval for Israeli drug company, Teva, to market its generic version of Risperdal, an antipsychotic agent manufactured by Janssen

The US Food and Drug Administration (FDA) has granted final approval for Israeli drug company, Teva, to market its generic version of Risperdal, an antipsychotic agent manufactured by Janssen.

Risperdal is used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. Generic versions of Risperdal (risperidone) will carry the same safety warnings as the branded drug, which includes a Boxed Warning about the off-label use of risperidone to treat dementia-related psychosis in older patients, which can lead to a higher risk of death.

"This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research.

As the first company to request general approval, (through an Abbreviated New Drug Application (ANDA)) Teva has been granted marketing exclusivity for 180 days.

Janssen's parent company, Johnson & Johnson, has launched its own generic version of Risperdal through another of its subsidiary companies, Patriot Pharmaceuticals. This will be a direct competition for Teva's drug.

IMS sales data shows that in the 2007/08 financial year, US sales of Risperdal brought in $42.6bn for Janssen.

1st July 2008

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