Approved Risk Evaluation and Mitigation Strategies (REMS)

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Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
Shared System REMS
REMS last update: 09/19/2016

This page reflects the most up-to-date version of this Shared System REMS. The process of making corresponding changes to all REMS in the shared system is underway.

What are Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) products?

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The Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Bunavail (buprenorphine and naloxone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 205637 Biodelivery Sciences International Inc. 06/06/2014
Zubsolv (buprenorphine and naloxone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 204242 Orexo US, Inc 09/04/2013
buprenorphine ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 201760 Sun Pharmaceutical Industries Limited 01/29/2016
buprenorphine and naloxone ( Info at Drugs@FDA ) ANDA 201633 Sun Pharm Inds LTD 08/05/2016
buprenorphine and naloxone ( Info at Drugs@FDA ) ANDA 205022 Kremers Urban Pharmaceuticals Inc 09/19/2016
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 078633 Roxane Laboratories, Inc. 02/22/2013
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090360 Barr Laboratories Inc 02/22/2013
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090622 Ethypharm US COR 02/22/2013
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090819 Actavis Elizabeth LLC 02/19/2015
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 201066 Mylan Pharmaceuticals Inc 03/06/2015
buprenorphine hydrochloride ( Info at Drugs@FDA ) ANDA 090279 Sandoz Inc. 06/10/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204431 Ethypharm USA Corp. 10/16/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203326 Roxane Laboratories, Inc. 06/27/2014
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091422 Actavis Elizabeth LLC 02/22/2013
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091149 Teva Pharmaceuticals USA 09/09/2014
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203136 Amneal Pharmaceuticals, LLC 02/22/2013

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 buprenorphine-containing transmucosal products for opioid dependence (BTOD) products

Before writing the first prescription for a patient
  • Assess patient to verify they meet the diagnostic criteria for opioid dependence.
  • Counsel the patient on the risks and safe storage of BTOD products.
  • Complete the Appropriate Use Checklist (or by using another method specific to the prescriber’s office practice).
  • Prescribe a limited amount of medication at the first visit.
While patient is being treated with a BTOD product
  • At intervals commensurate with patient stability, schedule a return visit. Weekly, or more frequent, visits are recommended during the first month.
  • At the return visit, assess the patient’s; compliance with the medication, appropriateness of dosage prescribed, receipt of necessary psychosocial support, and adequate progress towards treatment goals.
  • Complete the Appropriate Use Checklist (or by using another method specific to the prescriber’s office practice).

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:


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Material Name
Appropriate Use Checklist (PDF)
BTOD REMS Website Screenshots (PDF)
Dear Pharmacist Letter (PDF)
Dear Prescriber Letter (PDF)
Pharmacist Brochure, "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists" (PDF)
Prescriber Brochure, "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers" (PDF)
REMS document (PDF)
REMS full (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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