Cancer Therapy

Company to challenge FDA delay of manufactured tamoxifen launch

Published in Cancer Weekly, November 5th, 2002

Barr Laboratories, Inc., (BRL) has announced that it disagrees with a letter, received from the U.S. Food and Drug Administration (FDA), which retroactively alters the approval date of Barr's application for tamoxifen 10 mg tablets.

Barr said that it will file a court action in the U.S. District Court for the District of Columbia, seeking to reaffirm the April 1987 FDA final approval of its tamoxifen product, which established August 20, 2002, as the effective launch date for the company's product. If the FDA decision is upheld, it would delay the launch of Barr's manufactured tamoxifen 10-mg tablets until the expiration of pediatric exclusivity in February...

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Source: Cancer Weekly (2002-11-05)

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