Approved Risk Evaluation and Mitigation Strategies (REMS)

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Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
Shared System REMS
REMS last update: 09/30/2016

What are Extended-Release and Long-Acting (ER/LA) Opioid Analgesics products?

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm

Select to View Firm Press Release Download This List

The Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Arymo ER (morphine sulfate) ( Info at Drugs@FDA ) NDA 208603 Egalet Corp 01/09/2017
Belbuca (buprenorphine) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 207932 Endo Pharms INC 10/23/2015
Butrans (buprenorphine) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021306 Purdue Pharma LP 07/09/2012
Dolophine (methadone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 006134 Roxane Laboratories, Inc 07/09/2012
Duragesic (fentanyl transdermal system) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 019813 Janssen Pharmaceuticals, Inc 07/09/2012
Embeda (morphine sulfate and naltrexone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022321 Alpharma Pharmaceuticals LLS 07/09/2012
Exalgo (hydromorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021217 Mallinckrodt INC The Pharmaceuticals Business of Covidien 07/09/2012
Hysingla ER (hydrocodone bitartrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 206627 Purdue Pharma LP 11/20/2014
Kadian (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 020616 Allergan, Inc. 07/09/2012
Methadose (methadone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 040050 Mallinckrodt Pharmaceuticals 07/09/2012
Morphabond (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 206544 Inspirion Delivery Technologies LLC 10/02/2015
MS Contin (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 019516 Purdue Pharma LP 07/09/2012
Nucynta ER (tapentadol) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 200533 Depomed, Inc. 07/09/2012
Opana ER (oxymorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 201655 Endo Pharmaceuticals Inc 07/09/2012
Opana ER (oxymorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021610 Endo Pharmaceuticals Inc 07/09/2012
OxyContin (oxycodone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022272 Purdue Pharma LP 07/09/2012
Targiniq ER (oxycodone and naloxone hydrochloride) ( Info at Drugs@FDA ) NDA 205777 Purdue Pharma LP 07/23/2014
Troxyca ER (oxycodone hydrochloride and naloxone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 207621 Pfizer, Inc 08/19/2016
Vantrela ER (hydrocodone bitartrate) ( Info at Drugs@FDA ) NDA 207975 Teva Branded Pharmaceuticals Products R and D, Inc. 01/17/2017
Xtampza (oxycodone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 208090 Collegium Pharmaceuticals, Inc. 04/26/2016
Zohydro ER (hydrocodone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 202880 Pernix Ireland Pain Limited 10/25/2013
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076258 Mylan Technologies Inc. 07/09/2012
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077154 Mallinckrodt Pharmaceuticals 07/09/2012
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077449 Aveva Drug Delivery Systems, Inc. (An Apotex Company) 02/14/2013
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077062 Par Pharmaceuticals Inc. 07/09/2012
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076709 Actavis Laboratories UT INC 07/09/2012
hydrocodone bitartrate extended-release ( Info at Drugs@FDA ) ANDA 206952 Actavis Laboratories FL, Inc 08/26/2016
hydromorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202144 Actavis Laboratories UT INC 05/12/2014
hydromorphone hydrochloride extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204278 Paddock Laboratories, LLC 04/06/2015
hydromorphone hydrochloride extended-release ( Info at Drugs@FDA ) ANDA 205629 Osmotica 07/07/2016
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090065 CorePharma, LLC 08/18/2015
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203502 Aurolife Pharma LLC 08/31/2015
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 040241 Sandoz Inc. 07/09/2012
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090635 The Pharma Network, LLC 07/09/2012
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 090707 Vistapharm INC 11/02/2012
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 040517 Mallinckrodt Pharmaceuticals 07/09/2012
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 087997 Roxane Laboratories, Inc 07/09/2012
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 087393 Roxane Laboratories, Inc 07/09/2012
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 089897 Roxane Laboratories, Inc 07/09/2012
morphine sulfate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200824 Mylan Pharmaceuticals, Inc 07/09/2012
morphine sulfate extended release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202104 Upsher-Smith 06/03/2013
morphine sulfate extended release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200411 Impax Laboratories, Inc. 04/12/2016
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 205634 Sun Pharmaceutical Industries, Inc. 08/25/2016
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203602 Novel Laboratories, Inc. 12/16/2015
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 091357 CorePharma, LLC 06/23/2016
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200812 Par Pharmaceuticals, Inc. 04/24/2013
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 075295 Vintage Pharmaceuticals LLC 07/09/2012
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 202718 Teva Pharmaceuticals USA 12/29/2014
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 203849 Actavis Elizabeth LLC 04/06/2015
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 077855 Nesher Pharms 05/08/2015
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076720 Nesher Pharms 05/08/2015
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076733 Nesher Pharms 05/08/2015
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 078761 Sun Pharmaceutical Industries LTD 04/15/2013
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 074769 Rhodes Pharmaceuticals L.P. 07/09/2012
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 074862 Rhodes Pharmaceuticals L.P. 07/09/2012
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076412 Mallinckrodt Pharmaceuticals 07/09/2012
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076438 Mallinckrodt Pharmaceuticals 07/09/2012
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079040 Actavis Elizabeth, LLC 01/16/2013
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 205386 Mayne Pharma Inc 10/28/2016
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079087 Impax Laboratories, Inc. 10/12/2012
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079046 Actavis Elizabeth, LLC 07/09/2012
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202946 Mallinckrodt Pharmaceuticals 06/27/2014
oxymorphone hydrochloride extended release ( Info at Drugs@FDA ) ANDA 200822 Roxane Laboratories, Inc 07/15/2013
oxymorphone hydrochloride extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203506 Sun Pharmaceutical Industries Limited 04/24/2015

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe extended-release long-acting opioid analgesic products

  • Receive training provided by the accredited CE provider.
  • Complete the REMS-compliant training, including the knowledge assessment.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Select to View Firm Press Release Download This List

Material Name
FDA Blueprint for Prescriber Education with table of product specific drug information (PDF)
FDA Blueprint for Prescriber Education (PDF)
Patient Counseling Document (PCD) (PDF)
Prescriber Letter 1 (PDF)
Prescriber Letter 2 (PDF)
Prescriber Letter 3 (PDF)
Professional Organization/Licensing Board Letter 1 (PDF)
Professional Organization/Licensing Board Letter 2 (PDF)
REMS document (PDF)
REMS full (PDF)
REMS Website Screenshots (PDF)

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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