First standardized REMS approved

Traynor, Kate
March 2011
American Journal of Health-System Pharmacy;3/1/2011, Vol. 68 Issue 5, p366
Academic Journal
The article reports that ProStraken Inc.'s Abstral tablets is the first product with a standardized risk mitigation and evaluation strategy (REMS) to be approved by the Food and Drug Administration (FDA). It states that the REMS for these immediate release fentanyl transmucosal tablets, is intended to provide the drug to opioid-tolerant patients only. The article also mentions that the Abstral REMS includes standardized components, a medication guide and elements to assure safe use (ETASU).


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