Durect announces submission to FDA of a full response to the Posimir complete response letter

Durect

27 June 2019 - Durect Corporation today announced it has submitted a full response to the complete response letter it previously received from U.S. FDA related to Posimir (bupivacaine extended-release solution).

The submission is intended to address the issues raised in the letter and seeks FDA approval of Posimir based on what the Company and its advisors believe is adequate evidence of both safety and efficacy.

Read Durect press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier