Additional Information on Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics REMS

The documents linked on this page have been redacted for certain information that is exempt from disclosure under the Freedom of Information Act, 5 U.S.C. sec. 552. This includes, for example, trade secret information, confidential commercial information, predecisional/deliberative-process information, and personal privacy information. The full text of any published materials within this document collection, including newspaper and journal articles, will not be posted to this website because such material is copyright protected.

ER-LA REMS Six-Month Assessment Report, December 12, 2012
ER-LA REMS Twelve-Month Assessment Report, June 28, 2013
ER-LA REMS Twenty-Four Month Assessment Report, June 26, 2014
ER-LA FDA Deferral of REMS Review, September 2, 2015
ER-LA FDA Final REMS Modification Review, June 25, 2015
ER-LA FDA Final REMS Modification Review, September 27, 2016
ER-LA FDA Final REMS Modification Review, May 25, 2017
ER-LA FDA Final REMS Review, July 6, 2012
ER-LA FDA Final REMS Review, April 20, 2016
ER-LA FDA Interim Comments on REMS Modification Set 1, January 25, 2013
ER-LA FDA Letter on REMS Acknowledgment for the ER-LA Opioid REMS, October 24, 2013
ER-LA FDA REMS Modification Review, August 18, 2014
ER-LA FDA REMS Modification Review, April 12, 2015
ER-LA FDA REMS Modification Review, August 26, 2015
ER-LA FDA REMS Modification Review, February 24, 2016
ER-LA FDA Review of Forty-Eight Month REMS Assessment Report, August 10, 2017
ER-LA FDA Review of Proposed Methodology and Survey Instruments for REMS Assessment, January 11, 2013
ER-LA FDA Review of Six Month REMS Assessment Report, February 14, 2012
ER-LA FDA Review of Sixty Month REMS Assessment Report, February 14, 2018
ER-LA FDA Review of Thirty-Six Month REMS Assessment Report, June 29, 2016
ER-LA FDA Review of Twelve Month REMS Assessment Report, August 30, 2013
ER-LA FDA Review of Twenty-Four Month REMS Assessment Report, February 26, 2015