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TAP Lupron approvals and audits

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

One-month and three-month formulations of TAP's GnRH agonist Lupron Depot are approved Sept. 21 for the initial management of endometriosis and management of recurrence of symptoms. On Oct. 3, the Department of Justice announced that TAP agreed to pay $875 mil. to resolve criminal charges related to violations of the Prescription Drug Marketing Act and the False Claims Act in Lupron prostate cancer promotions. The firm also agreed to annual audits of Lupron and Prevacid sales and marketing by independent reviewers
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