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: 05/26/2017

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Arymo ER (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 208603 EGALET 01/09/2017 setid=e60552c9-06ce-4790-95e7-aadd4df12b2a http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208603
Belbuca (buprenorphine) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 207932 BDSI 10/23/2015 setid=69df676c-0357-4e67-a92d-f6b337b34a2f http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207932
Butrans (buprenorphine) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021306 PURDUE PHARMA LP 07/09/2012 setid=794aa355-66de-41b8-aedf-f2c40f6bc664 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021306
Dolophine (methadone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 006134 WEST-WARD PHARMS INT 07/09/2012 setid=4a3b2bc3-d837-4ca9-aee1-452633b6a06b http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=006134
Duragesic (fentanyl transdermal system) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 019813 JANSSEN PHARMS 07/09/2012 setid=d7aade83-9e69-4cd5-8dab-dbf1d7b89bb4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=019813
Embeda (morphine sulfate and naltrexone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022321 ALPHARMA PHARMS 07/09/2012 setid=dfe97a3d-247d-4dda-a641-1a95196cd8d8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022321
Exalgo (hydromorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021217 MALLINCKRODT INC 07/09/2012 setid=22e635cb-98c0-e4f9-6a71-62d7487a0a6c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021217
Hysingla ER (hydrocodone bitartrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 206627 PURDUE PHARMA LP 11/20/2014 setid=b7d23ac2-e776-9f62-3290-c64c2d6eb353 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206627
Kadian (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 020616 ALLERGAN SALES LLC 07/09/2012 setid=4598407c-11cc-4f04-8acb-723f97aa16b8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020616
Methadose (methadone hydrochloride) ( Info at Drugs@FDA ) ANDA 040050 MALLINCKRODT 07/09/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=040050
Morphabond (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 206544 DAIICHI SANKYO INC 10/02/2015 setid=1806c935-0a76-4f6a-80c8-4aee8a95cb7d http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206544
MS Contin (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 019516 PURDUE PHARMA LP 07/09/2012 setid=e0472c35-3f44-42e2-9b75-37b2e9ff65f6 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=019516
Nucynta ER (tapentadol) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 200533 DEPOMED INC 07/09/2012 setid=f4c911f3-484b-44fa-833e-2d970d39be8f http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200533
Opana ER (oxymorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 201655 ENDO PHARMS 07/09/2012 setid=e6e34c18-fbc6-4cab-9aed-0905d93c2ab6 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=201655
Opana ER (oxymorphone hydrochloride) ( PI at DailyMed , Info at Drugs@FDA ) NDA 021610 ENDO PHARMS 07/09/2012 setid=0ae0e103-5250-4745-8ae2-74fa47fbf973 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021610
OxyContin (oxycodone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022272 PURDUE PHARMA LP 07/09/2012 setid=bfdfe235-d717-4855-a3c8-a13d26dadede http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022272
Targiniq ER (oxycodone and naloxone hydrochloride) ( Info at Drugs@FDA ) NDA 205777 PURDUE PHARMA LP 07/23/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205777
Troxyca ER (oxycodone hydrochloride and naloxone hydrochloride) ( Info at Drugs@FDA ) NDA 207621 PFIZER INC 08/19/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207621
Vantrela ER (hydrocodone bitartrate) ( Info at Drugs@FDA ) NDA 207975 TEVA BRANDED PHARM 01/17/2017 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207975
Xtampza (oxycodone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 208090 COLLEGIUM PHARM INC 04/26/2016 setid=b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208090
Zohydro ER (hydrocodone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 202880 PERNIX IRELAND PAIN 10/25/2013 setid=cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202880
fentanyl transdermal system ( PI at DailyMed , Info at Drugs@FDA ) ANDA 077154 MALLINCKRODT INC 07/09/2012 setid=67cb9ea4-5adb-4a3a-9568-266b6f472078 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077154
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077449 AVEVA 02/14/2013 setid=51ed4fe8-61fd-499d-abf3-d363f4c096e4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077449
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076258 MYLAN TECHNOLOGIES 07/09/2012 setid=2a2238e9-4b5d-c56d-8663-dd354ff9ae0c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076258
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077062 MAYNE PHARMA 07/09/2012 setid=245a75e6-3b45-4dc6-bc58-2e33196faca0 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077062
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076709 ACTAVIS LABS UT INC 07/09/2012 setid=9baf2912-9d0f-412a-8fbf-617f6a4f91ed http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076709
hydrocodone bitartrate extended-release ( Info at Drugs@FDA ) ANDA 206952 ACTAVIS LABS FL INC 08/26/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206952
hydromorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202144 ACTAVIS LABS FL INC 05/12/2014 setid=5a717315-250b-4e2d-b315-3ae1b6c337f9 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202144
hydromorphone hydrochloride extended-release ( Info at Drugs@FDA ) ANDA 205629 OSMOTICA 07/07/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205629
hydromorphone hydrochloride extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204278 PADDOCK LLC 04/06/2015 setid=780a2616-0392-4715-bc50-71799bea1957 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204278
methadone hydrochloride ( PI at DailyMed , Info at Drugs@FDA ) ANDA 203502 AUROLIFE PHARMA LLC 08/31/2015 setid=6984eb5a-57a3-4686-bc67-91bc3e7a531e http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203502
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 090065 EPIC PHARMA LLC 08/18/2015 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090065
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 040517 MALLINCKRODT 07/09/2012 setid=eddf7077-02fb-4771-9823-31984f4ff2bb http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=040517
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 040241 SANDOZ 07/09/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=040241
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090635 THE PHARMANETWORK 07/09/2012 setid=aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090635
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 090707 VISTAPHARM 11/02/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090707
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 087997 WEST-WARD PHARMS INT 07/09/2012 setid=8C363F90-C378-48AE-ABBC-AEB25C9BF5CB http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=087997
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 087393 WEST-WARD PHARMS INT 07/09/2012 setid=8C363F90-C378-48AE-ABBC-AEB25C9BF5CB http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=087393
methadone hydrochloride ( PI at DailyMed , Info at Drugs@FDA ) ANDA 089897 WEST-WARD PHARMS INT 07/09/2012 setid=E72841BF-364B-49B1-8E69-7E26DDCD2657 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=089897
morphine sulfate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200824 MYLAN PHARMS INC 07/09/2012 setid=ff61d8e8-ea48-43be-828f-de13a9746b5e http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200824
morphine sulfate extended release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200411 IMPAX LABS INC 04/12/2016 setid=f7e9a4b3-a2ee-4f0a-becd-6ef90867332b http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200411
morphine sulfate extended release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202104 UPSHER-SMITH LABS 06/03/2013 setid=97948a8f-7d1b-4614-b11d-e944cf56590b http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202104
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 075295 VINTAGE PHARMS LLC 07/09/2012 setid=a07378f9-607a-49c6-bdb8-5c8b4ce91a49 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=075295
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 202718 TEVA PHARMS USA 12/29/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202718
morphine sulfate extended-release ( PI at DailyMed , Info at Drugs@FDA ) ANDA 200812 PAR PHARM INC 04/24/2013 setid=0e56601d-1c78-4258-9106-40c19a92cca8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200812
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203602 NOVEL LABS INC 12/16/2015 setid=e044604d-f210-4411-a6e8-6a9dbdb1a9bd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203602
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203849 ACTAVIS ELIZABETH 04/06/2015 setid=75fb4282-0bbd-4d63-a7d1-5142780a4fae http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203849
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 077855 NESHER PHARMS 05/08/2015 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077855
morphine sulfate extended-release ( PI at DailyMed , Info at Drugs@FDA ) ANDA 076720 NESHER PHARMS 05/08/2015 setid=1a2c9474-fab6-41a0-844d-d6bd5e6a4341 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076720
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076733 NESHER PHARMS 05/08/2015 setid=7fc20bfa-86c2-40a0-be8e-8f5447bcee44 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076733
morphine sulfate extended-release ( PI at DailyMed , Info at Drugs@FDA ) ANDA 205634 SUN PHARM INDS 08/25/2016 setid=6208902e-4e2f-4b91-8a24-29f122aa7b24 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205634
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 091357 EPIC PHARMA LLC 06/23/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091357
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 205386 MAYNE PHARMA INC 10/28/2016 setid=053e3fd9-25fc-4b55-b683-63fb9d190dae http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205386
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079040 ACTAVIS ELIZABETH 01/16/2013 setid=2da87bfa-11fd-43e3-8fef-d16ebeb15680 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079040
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 078761 SUN PHARM INDS LTD 04/15/2013 setid=736c9b80-682c-4cda-bf18-61b18de0bd39 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=078761
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 074769 RHODES PHARMS 07/09/2012 setid=19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=074769
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 074862 RHODES PHARMS 07/09/2012 setid=19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=074862
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076412 MALLINCKRODT 07/09/2012 setid=533034fd-c8e7-495b-8874-0db41bd1e65a http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076412
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076438 MALLINCKRODT 07/09/2012 setid=533034fd-c8e7-495b-8874-0db41bd1e65a http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076438
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079087 IMPAX LABS 10/12/2012 setid=557e9610-62d7-42bf-90c1-44215bd8c1f8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079087
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079046 ACTAVIS ELIZABETH 07/09/2012 setid=468bc2c3-9af3-4db1-b079-f2b5b98e951d http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079046
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202946 MALLINCKRODT INC 06/27/2014 setid=6e36199a-1536-4cd4-8a04-0cbd0acfb4a5 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202946
oxymorphone hydrochloride extended release ( Info at Drugs@FDA ) ANDA 200822 WEST-WARD PHARMS INT 07/15/2013 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200822
oxymorphone hydrochloride extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203506 SUN PHARM INDS LTD 04/24/2015 setid=e6b1c980-bb0c-4805-8e0d-9f8f8e9bfdde http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203506

What is the purpose of the REMS?

The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

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.

View additional drug-specific postmarket safety information from the FDA

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. For a specific Medication Guide of a product in the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
FDA Blueprint for Prescriber Education with table of product specific drug information (PDF)  
Patient Counseling Document (PCD) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Patient_Counseling_Document_PCD.pdf
Prescriber Letter 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Prescriber_Letter_1.pdf
Prescriber Letter 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Prescriber_Letter_2.pdf
Prescriber Letter 3 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Prescriber_Letter_3.pdf
Professional Organization/Licensing Board Letter 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Professional_Organization_Licensing_Board_Letter_1.pdf
Professional Organization/Licensing Board Letter 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Professional_Organization_Licensing_Board_Letter_2.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
05/26/2017 Modified to align the REMS document and materials with the labeling approved on December 16, 2016, as well as additional minor modifications.
09/30/2016 Modified to relocate the product-specific information section from the Blueprint for Prescriber Education to the FDA website located at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM515636.pdf.
08/19/2016 Modified to add Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) product information to the shared system REMS.
04/26/2016 Modified to add Xtampza ER (oxycodone) product information to the shared system REMS.
04/20/2016 Modified to include the following information in the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education:

  1. Incorporate information regarding the use of OxyContin in the pediatric population.
  2. Add information to the titration recommendations of OxyContin for adult patients.
  3. Add product-specific information for a recently approved ER/LA opioid analgesic, MorphaBond (morphine sulfate extended release) tablets.
  4. Add product-specific information for a recently approved ER/LA opioid analgesic, Belbuca (buprenorphine) buccal film.
10/23/2015 Modified to add the Belbuca (buprenorphine), product to the shared system REMS.
10/02/2015 Modified to add the Morphabond (morphine sulfate) product to the shared system REMS.
08/13/2015 Modified to:

  1. Incorporate information regarding use of OXYCONTIN in the pediatric population
  2. Add information to the titration recommendations for adult patients.
06/26/2015 Modified to:

  1. Change the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education to incorporate:
    1. Product-specific information for a recently approved ER/LA opioid analgesic, Hysingla ER (hydrocodone bitartrate extended-release) tablets.
    2. Newly approved intermediate strengths of fentanyl transdermal systems.
    3. Revised titration information for Dolophine (methadone HCl tablets).
12/29/2014 Modified to add three new dosage strengths for fentanyl transdermal system [ANDA 076258].
11/20/2014 Modified to add the Hysingla ER product to the shared system REMS.
08/19/2014 Modified to:

  1. Incorporate the following safety labeling changes to the ER/LA Opioid Analgesics REMS Blueprint, ER/LA opioid analgesic REMS Website, and the Dear Prescriber Letter (DHCP) letter:
    1. New indication for ER/LA opioid analgesics.
    2. New warning for Neonatal Opioid Withdraw Syndrome (NOWS).
    3. Updated language for the following Warnings and Precautions:
      1. Addiction, Abuse, and Misuse
      2. Life-Threatening Respiratory Depression
      3. Accidental Ingestion
      4. Cytochrome P450 3A4 Interaction (for applicable products)
    4. Revisions to the Blueprint to incorporate updated product-specific titration language.
  2. Change the ER/LA Opioid Analgesics REMS Blueprint to include product-specific information for ER/LA opioids approved after the last ER/LA REMS modification on April 15, 2013
07/23/2014 Modified to add the Targiniq ER product to the shared system REMS.
06/30/2014 Modified to add the 7.5 mcg/hour intermediate dosage strength [to the Butrans (buprenorphine) Transdermal System] to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics.
10/25/2013 Modified to add the Zohydro product to the shared system REMS.
04/15/2013 Modified to:
  1. Revise Section VI. Specific Drug information for ER/LA Opioid Analgesic Products of the FDA Blueprint.
  2. Revise the REMS Website, including the landing page and the webpage listing covered products under the REMS program.
  3. Revise the individual product Medication Guides for relevant drugs.
  4. Revise the REMS document to remove ANDA holders from the Timetable for Submission of Assessments.
08/28/2012 Modified to:
  1. Add Nucynta ER REMS product information to the shared system.
  2. Make technical corrections to the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (FDA Blueprint).
07/09/2012 Approval of the REMS.

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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