Skip to Content

Zalviso Approval Status

  • FDA approved: No
  • Brand name: Zalviso
  • Generic name: sufentanil
  • Company: AcelRx Pharmaceuticals, Inc.
  • Treatment for: Pain

Zalviso (sufentanil sublingual microtablet system) is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

Development Status and FDA Approval Process for Zalviso

May  4, 2015AcelRx Pharmaceuticals Provides Zalviso Regulatory Update
Mar  9, 2015AcelRx Provides Regulatory Update on Zalviso
Jul 25, 2014AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for NDA for Zalviso
Dec  2, 2013Zalviso New Drug Application Accepted for Filing by FDA
Sep 30, 2013AcelRx Pharmaceuticals Submits New Drug Application to the FDA for Zalviso

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.