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Failure to Request FDA Approval
Date: 10/11/2002 (Date of Violation Notification)
Misconduct Type: Health
Enforcement Agency: Health and Human Servs.
Contracting Party: None
Court Type: Administrative
Disposition: Administrative Agreement
Synopsis: On October 11, 2002 the FDA submitted a letter to Amerisource Health Services Corporation, a subsidiary of AmerisourceBergen, in reference to the firm’s marketing of Humibid LA Tablets. The FDA had recently approved a similar drug; however, Amerisource had not received approval for Humibid. Marketing this new drug without FDA approval violated the Federal Food, Drug, and Cosmetic Act and required Amerisource to bring its marketing efforts into compliance with the act.