Schizophrenia

Barr receives tentative approval for generic version of Zyprexa Zydis

Published in Medical Letter on the CDC and FDA, December 17th, 2006

Barr Pharmaceuticals, Inc. (BRL) announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's Zyprexa Zydis (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg.

The company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.

The patent listed in the Orange Book for Zyprexa Zydis expires on April 23, 2011. Barr's Abbreviated New Drug Application (ANDA) alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Barr's...

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Source: Medical Letter on the CDC and FDA (2006-12-17)

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