Regulatory Actions

Mylan Receives FDA Approval for Generic Version of Anti-Psychotic Risperdal(R)

Published in Drug Law Weekly, September 30th, 2008

Mylan Inc. (NYSE:MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

Risperidone Tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen's Risperdal(R) Tablets. This product had annual U.S. sales of approximately $2.67 billion for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.

Mylan will ship the product shortly. Currently, the company has 109 ANDAs pending FDA approval,...

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Source: Drug Law Weekly (2008-09-30)

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