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Zalviso FDA Approval Status

FDA Approved: No
Brand name: Zalviso
Generic name: sufentanil
Dosage form: Sublingual Microtablet System
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.

In July 2014, AcelRx Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Zalviso.

Development timeline 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

Further information

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