Approved Risk Evaluation and Mitigation Strategies (REMS)
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
Shared System REMS
REMS last update: 12/16/2022
What medicines are included in the REMS?
Product Name | Application Number | Application Holder | Added to REMS | DailyMed Link | FDA Link |
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Bunavail (buprenorphine and naloxone) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 205637 | BDSI | 06/06/2014 | 12b963dd-f189-11e3-ac10-0800200c9a66 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205637 |
Cassipa (buprenorphine and naloxone) (Info at Drugs@FDA) | NDA 208042 | TEVA PHARMS USA | 09/07/2018 | ||
Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) (Info at Drugs@FDA) | NDA 022410 | INDIVIOR INC | 05/03/2022 | ||
Zubsolv (buprenorphine and naloxone) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 204242 | OREXO US INC | 09/04/2013 | 5f5cfcfe-d52b-49e6-8fe4-550477332dd2 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204242 |
buprenorphine ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 201760 | SUN PHARM | 01/29/2016 | 9fd1f18f-0b0f-4059-b603-19ecbf0ed63a | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=201760 |
buprenorphine ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 207276 | RHODES PHARMS | 03/27/2017 | da90618a-5621-4b15-bc48-9dcc631418de | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207276 |
buprenorphine and naloxone ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 207000 | SPECGX LLC | 12/13/2017 | 62abde41-46cb-4e90-a798-23d6531bf9aa | |
buprenorphine and naloxone ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 205806 | DR REDDYS LABS SA | 06/14/2018 | 72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2 | |
buprenorphine and naloxone ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 207607 | MYLAN TECHNOLOGIES | 06/14/2018 | d1ecf0e8-7816-490e-b3c0-e929cb5f76de | |
buprenorphine and naloxone (Info at Drugs@FDA) | ANDA 212756 | AVEVA | 06/03/2022 | ||
buprenorphine and naloxone ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 201633 | SUN PHARM | 08/05/2016 | 91b68606-05de-4586-ae31-07e8cc9160cf | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=201633 |
buprenorphine and naloxone ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 205022 | LANNETT CO INC | 09/19/2016 | 14eaa94a-cc8a-4e1e-8cfb-5c976c96c606 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205022 |
buprenorphine and naloxone (Info at Drugs@FDA) | ANDA 205601 | RHODES PHARMS | 03/31/2020 | ||
buprenorphine and naloxone (Info at Drugs@FDA) | ANDA 211785 | MYLAN TECHNOLOGIES | 04/20/2020 | ||
buprenorphine and naloxone (Info at Drugs@FDA) | ANDA 209069 | WES PHARMA INC | 07/17/2020 | ||
buprenorphine and naloxone (Info at Drugs@FDA) | ANDA 206953 | MAYNE PHARMA INC | 07/17/2020 | ||
buprenorphine and naloxone (Info at Drugs@FDA) | ANDA 214930 | ALKEM LABS LTD | 06/15/2021 | ||
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 090819 | ACTAVIS ELIZABETH | 02/19/2015 | 03819118-86f6-4329-adaf-4599e7b71f46 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090819 |
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 201066 | MYLAN | 03/06/2015 | 7a85f424-9d83-49d9-8a17-478abce6fddd | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=201066 |
buprenorphine hydrochloride ( Info at Drugs@FDA ) | ANDA 090279 | RUBICON | 06/10/2015 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090279 | |
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 078633 | HIKMA | 02/22/2013 | 1bf8b35a-b769-465c-a2f8-099868dfcd2f | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=078633 |
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 090360 | BARR | 02/22/2013 | 593aa0cf-bbcd-14b5-e053-2a91aa0a13e5 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090360 |
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 090622 | ETHYPHARM | 02/22/2013 | a891f3ff-5cad-4e92-b4c4-d5108c8df550 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090622 |
buprenorphine hydrochloride and naloxone hydrochloride ( PI at DailyMed , Info at Drugs@FDA , Info at Drugs@FDA ) | ANDA 205954 | ALVOGEN | 01/24/2019 | 4210afeb-474c-d842-d68e-af7e0021851a | |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 091422 | ACTAVIS ELIZABETH | 02/22/2013 | 6cccf229-9611-4b6f-8f1b-acc8ff1ed3f8 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091422 |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 203136 | AMNEAL PHARMS | 02/22/2013 | 17b63f10-c9df-44be-80fa-6f1c305583b8 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203136 |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 091149 | TEVA PHARMS USA | 09/09/2014 | b39c724f-7dc1-4213-8671-83c34a82268a | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091149 |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 204431 | ETHYPHARM USA CORP | 10/16/2015 | 47236a95-ba0b-4f6a-b406-858cabc726df | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204431 |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 203326 | HIKMA | 06/27/2014 | 713db2c6-0544-4633-b874-cfbeaf93db89 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203326 |
buprenorpine and naloxone ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 205299 | DR REDDYS LABS SA | 06/14/2018 | 718756d7-0131-b173-6c45-5ee039b311b0 |
What is the purpose of the REMS?
The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
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
Prescribers who prescribe or dispense buprenorphine transmucosal products for opioid dependence (BTOD) must:
Before treatment initiation (first dose) |
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During treatment; at the first visit following induction |
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During treatment; at visits scheduled at intervals commensurate with patient stability |
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Patients who are prescribed buprenorphine transmucosal products for opioid dependence:
Before treatment initiation |
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During treatment; at time intervals determined by your prescriber |
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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 Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) REMS, see the DailyMed link on the Products tab.
Material Name | Material Name Link |
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Appropriate Use Checklist (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Appropriate_Use_Checklist.pdf |
Dear Pharmacist Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Dear_Pharmacist_Letter.pdf |
Dear Prescriber Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Dear_Prescriber_Letter.pdf |
Pharmacist Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Pharmacist_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence.pdf |
Prescriber Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Prescriber_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_REMS_Website_Screenshots.pdf |
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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12/16/2022 | Modified to:
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05/03/2022 | Modified to:
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10/30/2020 | Revised to make editorial changes. |
10/31/2018 | Modified to align the REMS document and materials with the approved labeling. Those labeling changes pertained to the risks of life-threatening respiratory depression and death with concomitant use of buprenorphine with benzodiazepines or other CNS depressants, and additional revisions to the Package Insert. |
09/07/2018 | Modified to add Cassipa (buprenorphine and naloxone) product information. |
05/23/2017 | Modified to align the REMS document and materials to the labeling approved on December 16, 2016, as well as additional minor modifications. |
01/23/2017 | Revised to correct a typographical error(s). |
10/04/2016 | Modified to include the proposed new strength into the Dose Comparison Chart included in both the Prescriber Brochure, "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers" and the Pharmacist Brochure, "Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists." |
07/27/2016 | Revised to correct a typographical error(s). |
07/07/2016 | Modified to provide more succinct and clearer risk information for prescribers and pharmacists in the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists Brochure, Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers Brochure the Appropriate Use Checklist, Dear Prescriber Letter, and Dear Pharmacist Letter. |
08/10/2015 | Modified to update language to permit the use of Zubsolv for the initial (“induction”) treatment of opioid dependence in the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists brochure and the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers brochure. |
06/04/2015 | Modified to add a new strength of Zubsolv: 2.9 mg buprenorphine/ 0.71 mg naloxone to the REMS appended materials. |
02/12/2015 | Modified to:
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06/06/2014 | Modified to add Bunavail (buprenorphine and naloxone) product information to the shared system REMS. |
09/04/2013 | Modified to:
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02/22/2013 | 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.