Skip to main content

Zubsolv FDA Approval History

FDA Approved: Yes (First approved July 3, 2013)
Brand name: Zubsolv
Generic name: buprenorphine and naloxone
Dosage form: Sublingual Tablets
Company: Orexo AB
Treatment for: Opioid Use Disorder

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Development timeline for Zubsolv

Oct 11, 2023Orexo announces data from the MODIA study evaluating impact on use of illicit opioids
Oct 28, 2022Last patient enrolled in study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/ naloxone for the treatment of OUD
Oct  6, 2016Approval FDA Approves Unique Low Dosage of Zubsolv
Aug 11, 2015Approval FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence
Dec 12, 2014Approval FDA Approves Two Higher Dosage Strengths of Zubsolv
Jul  8, 2013Approval FDA Approves Zubsolv for the Maintenance Treatment of Opioid Dependence
Nov 19, 2012Orexo announces that Zubsolv has been accepted for review by the U.S. Food and Drug Administration (FDA)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.