TITLE

First standardized REMS approved

AUTHOR(S)
Traynor, Kate
PUB. DATE
March 2011
SOURCE
American Journal of Health-System Pharmacy;3/1/2011, Vol. 68 Issue 5, p366
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
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).
ACCESSION #
58638846

 

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