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 

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