Approval for Zubsolv
August 11, 2015 – Orexo announced U.S. Food and Drug Administration approval of a new indication for Zubsolv (buprenorphine/naloxone) C111 sublingual tablets. The indication for this new approval is to induce buprenorphine maintenance therapy for patients who are dependent on opioids. This is in addition to its original approval as maintenance treatment of opioid dependence.
Maintenance therapy is introduced by gradually lowering the dose of the opioid while the patient begins taking Zubsolv. Zubsolv is usually taken once daily and the tablets should be allowed to dissolve under the tongue, this may take at least five minutes. When Zubsolv therapy is started, patients should be supervised and should only be prescribed in small amounts. In fact, only qualified physicians who have unique identification numbers can prescribe Zubsolv. Therapy should also include support groups and counseling.
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.