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 05/12/2021
Outcome Date 05/13/2021
Outcome FDA approved HTX-011 on May 13, 2021, under brand name ZYNRELEF, for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty
Drug Status The drug was issued a Complete Response Letter by FDA in Jun.29, 2020, relating to non-clinical information
Rival Drugs Pacira Biosciences' Exparel
Market Potential Jefferies analysts expect HTX-011 to make around $545 million in peak sales
Other Approvals In Europe, HTX-011 will be marketed under brand name ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. Approved in September 2020, ZYNRELEF is expected to be available to patients in Europe during 2022.
Heron Therapeutics' Zynrelef Gets FDA Approval For Managing Post-Operative Pain For 72 Hours
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