Home » Generic Drugmaker Cited for Making Unapproved Drugs, Not Reporting Adverse Events
Generic Drugmaker Cited for Making Unapproved Drugs, Not Reporting Adverse Events
September 14, 2006
Icelandic generic drugmaker Actavis failed to conduct a follow-up investigation of a fatal adverse event, did not submit required reports on adverse drug experiences (ADEs) to the FDA and “manufactures numerous prescription drug products without approved applications,” the agency said in a warning letter to the firm.
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