New Strength for Zubsolv
June 10, 2015 – The U.S. Food and Drug Administration approved a new, medium strength of Orexo’s Zubsolv® (buprenorphine/naloxone) CIII sublingual. The new strength is a 2.9 mg/0.71 mg (buprenorphine/naloxone) dosage. Zubsolv is currently available strengths of 1.4 mg/0.36 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg and 11.4 mg/2.9 mg sublingual tablets. Originally, Zubsolv was approved on July 3, 2013 for the maintenance treatment of opioid dependence. The availability of the new strength will help some patients achieve their required dose with a single tablet. The new 2.9 mg/0.71 mg dosage strength is expected to be launched during second half of 2015.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.