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Company to challenge FDA delay of manufactured tamoxifen launch.
2002 NOV 7 - (NewsRx.com & NewsRx.net) -- 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 2003.
"We believe that the FDA unequivocally gave Barr final approval to launch our manufactured tamoxifen product in April of 1987. That approval clearly established August 20, 2002, as the effective date of our approval," said Bruce L. Downey, Barr's chairman and CEO. "We believe that the FDA's interpretation that pediatric exclusivity now applies is in error and we intend to vigorously pursue our right to launch a manufactured product during the pediatric exclusivity period. We are prepared, if cleared, to introduce our manufactured tamoxifen product, as soon as supplies of the product we distributed under agreement with AstraZeneca are depleted."
The company received final approval on April 2, 1987, to manufacture and ...
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Source: HighBeam Research, Company to challenge FDA delay of manufactured tamoxifen launch.