Business Update

Barr confirms generic Thalomid capsule application to the U.S. FDA

Published in Law and Health Weekly, January 27th, 2007

Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., (BRL), confirmed that it is seeking approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Celgene Corp.'s Thalomid (thalidomide) Capsules, 50 mg and 100 mg.

Barr filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Thalomid Capsules with the FDA in September 2006. As originally filed, that ANDA sought approval to manufacture and market the 200 mg strength. The company received notification of the application's acceptance for filing from the FDA on December 5, 2006. Following receipt of the...

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Source: Law and Health Weekly (2007-01-27)

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