Cancer Research

Barr Confirms Patent Challenge of TEMODAR

Published in Drug Law Weekly, August 7th, 2007

Barr Pharmaceuticals, Inc. (NYSE:BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed for Schering Corporation's TEMODAR(R) (Temozolomide) 5mg, 20mg, 100mg & 250mg capsules. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for TEMODAR.

Barr filed its ANDA containing a paragraph IV certification for a generic TEMODAR product with the U.S. Food & Drug Administration (FDA) in March 2007, and received notification of the application's acceptance for filing in June 2007. Following receipt of the notice from the FDA, Barr notified...

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Source: Drug Law Weekly (2007-08-07)

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