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Praecis Plenaxis user fee date

Executive Summary

FDA extends Praecis Plenaxis (abarelix) user fee date of Aug. 27 by 90 days during July 18 conference call with the company. "The agency has indicated that the company's proposed risk management program would need to include some form of controlled or managed distribution," Praecis says July 21. FDA raised concerns about the prostate cancer product's safety and efficacy in a June 2001 "not approvable" letter (1"The Pink Sheet" Sept. 24, 2001, p. 22)...
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