Application Nr Approved Date Route Status External Links
NDA207932 None Buccal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Belbuca Is Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. Belbuca Buccal Film Contains Buprenorphine, A Partial Opioid Agonist. Belbuca Is Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. ( 1 ) Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Long-Acting Opioid Formulations, Reserve Belbuca For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Immediate-Release Opioids) Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. ( 1 ) Belbuca Is Not Indicated As An As-Needed (prn) Analgesic. ( 1 ) Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Long-Acting Opioid Formulations [see Warnings And Precautions (5.1) ] , Reserve Belbuca For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Immediate-Release Opioids) Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. Belbuca Is Not Indicated As An As-Needed (prn) Analgesic.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE ZINC100373348

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