Barr to fight FDA Nolvadex ruling. (Life Sciences).(Brief Article)(Statistical Data Included)

Chemical Market Reporter, September, 2002 by Krause, Carey

BARR Laboratories Inc. has encountered a hurdle in its race to market a generic version of AstraZeneca PLC (AZ)'s breast cancer drug Nolvadex (tamoxifen). Last week, the Food and Drug Administration (FDA) retroactively altered the approval date of Barr's application for tamoxifen 10 mg tablets to February 2003, a six-month delay.

The company intends to file a court action seeking to reaffirm the April 1987 FDA final approval of its tamoxifen product, which established August 20, 2002, as the effective launch date. Barr expects a resolution by early October of its appeal in a district court. "The FDA has no authority to retroactively enforce the law," says the company Debate on the legal outcome affects tamoxifen forecasts of $85 million in the...

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