FDAnews Drug Daily Bulletin
Feb. 11, 2009 | Vol. 6 No. 28
FDA Seeks REMS for Opioid Painkiller Products
The FDA told 16 drugmakers that it will require risk evaluation and mitigation strategies (REMS) to help prevent abuse of opioid pain products such as transdermal patches. Letters were sent to brand and generic drug manufacturers — including Actavis, Purdue Pharma and Ortho-McNeil-Janssen — and posted on the agency’s website. Most of the affected products contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone and oxymorphone, John Jenkins, CDER’s director at the Office of New Drugs, said.
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