Legal Issues

Celgene notified of ANDA filing for thalidomide

Published in Cancer Law Weekly, January 13th, 2007

Celgene Corporation (CELG) announced that the company has been notified of an Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA), with a Paragraph IV certification, by Barr Pharmaceuticals, Inc.

This applicant is seeking authorization to market a generic version of thalidomide 200 mg tablets in the United States for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Celgene Corporation markets thalidomide under the brand name Thalomid and has approval to market as a treatment in combination with dexamethasone for newly diagnosed multiple myeloma, as well as for the acute...

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Source: Cancer Law Weekly (2007-01-13)

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