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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 204592/S-002
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`NDA 204592/S-004
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Iroko Pharmaceuticals LLC
`One Kew Place
`150 Rouse Boulevard
`Philadelphia, PA 19112
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`Attention:
`
`Paul M. Kirsch
`VP, Regulatory Affairs & Quality
`
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received October
`31, 2014, (S-002) and April 25, 2014, (S-004) submitted pursuant to section 505(b)(2) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Zorvolex (diclofenac) capsules, 18 mg and
`35 mg.
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`We acknowledge receipt of your amendments for S-002, dated December 27, 2013, and January
`29 and 31, and February 6, 2014.
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`Reference is also made to your email dated August 21, 2014, which included the final agreed-
`upon labeling.
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`These “Prior Approval” supplemental new drug applications propose the following:
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`S-002: Addition of a new indication for the management of osteoarthritis pain.
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`S-004: Changes to the medication guide, in response to our supplement request letter
`dated April 10, 2014.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`WAIVER OF HIGHLIGHTS SECTION
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of prescribing information.
`
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`Reference ID: 3615072
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`

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`NDA 204592/S-002
`NDA 204592/S-004
`Page 2
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`CONTENT OF LABELING
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` As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
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`The SPL will be accessible from publicly available labeling repositories.
`
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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`MARKET PACKAGE
`
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`Please submit one market package of the drug product when it is available to the following
`address:
`
`
`Swati Patwardhan
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
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`White Oak Building 22, Room: 3170
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`10903 New Hampshire Avenue
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`Silver Spring, MD
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`Use zip code 20903 if shipping via United States Postal Service (USPS).
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`Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL, FedEx).
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`Reference ID: 3615072
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`

`

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`NDA 204592/S-002
`NDA 204592/S-004
`Page 3
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` REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable due to the extremely limited incidence of osteoarthritis in the
`pediatric population.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`All promotional materials that include representations about your drug product must be promptly
`revised to be consistent with the labeling changes approved in this supplement, including any
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`should include prominent disclosure of the important new safety information that appears in the
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`Reference ID: 3615072
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`

`

`
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`Sincerely,
`
` {See appended electronic signature page}
`
`Sharon Hertz, MD
`Deputy Director
`Division of Anesthesia, Analgesia,
`and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`NDA 204592/S-002
`NDA 204592/S-004
`Page 4
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`
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`If you have any questions, call Swati Patwardhan, Regulatory Project Manager, at (301) 796-
`4085.
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`
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`ENCLOSURE:
`Content of Labeling
`
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`Reference ID: 3615072
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SHARON H HERTZ
`08/22/2014
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`Reference ID: 3615072
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`