April 06, 2004

Generic Risperdal

FDA tentatively OKs Generic Version of Risperdal antipsychotic

The U.S. Food and Drug Administration has tentatively approved a generic antipsychotic medicine from Mylan Laboratories Inc., the company said.

Risperidone is the generic form of Risperdal, a widely prescribed drug produced by Janssen Pharmaceutica Products LP to treat schizophrenia. Janssen is a New Jersey-based unit of Johnson & Johnson.

Mylan said its Risperidone application to the FDA was a so-called first-to-file opportunity. In those cases, pharmaceutical companies that are first-to-file applications and receive FDA approval are entitled to a period of exclusive marketing rights.


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