FDA Calendar

Company Name Heron Therapeutics Inc.
Drug Name HTX-011 (Resubmitted NDA)
Event Name FDA decision on HTX-011 for the management of postoperative pain
Event Date 06/26/2020
Outcome Date 06/29/2020
Outcome FDA issued Complete Response Letter for HTX-011 on Jun.29, 2020 again
Drug Status The drug was issued a Complete Response Letter in April 2019, also on issues related to chemistry, manufacturing and controls and non-clinical information.
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