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Sold as Zorvolex. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 14, 2026, FDA lists 2 applications for Diclofenac (sold as Zorvolex), first approved Oct 18, 2013, with 1 new use approved and 0 published complete response letters.
First approved: Oct 18, 2013
Applications: 2
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $338M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Zicthoru TapesA drug with a new indication and a new dosage for the analgesia and anti-inflammation in patients with lumbago, periarthritis scapulohumeralis,… · Hisamitsu Pharmaceutical Co., Inc. · Jun 20, 2022
Zicthoru Tapes, new approvalA drug with a new indication in a new dosage form for analgesia in various types of cancer. · Hisamitsu Pharmaceutical Co., Inc. · Mar 23, 2021
Clinical Trials
68 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA