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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` Food and Drug Administration
` Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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` NDA 202514/S003
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` NDA 202514/S004
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` Oak Pharmaceuticals, Inc.
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` Attention: Sam Boddapati, PhD
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` Vice President, Regulatory Affairs
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` 1925 West Field Court, Suite 300
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` Lake Forest, OL 60045
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` Dear Dr. Boddapati:
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` Please refer to your Supplemental New Drug Applications (sNDAs) submitted under section
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` 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for ZIOPTAN (tafluprost
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` ophthalmic solution), 0.0015% as follows:
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` Supplement # Submission date Receipt date
` Provides for
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` July 19, 2013 Revisions to the How Supplied/Storage and
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` S-003 (Prior
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` July 18, 2013
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`Approval)
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` Handling, Patient Counseling Information,
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` Patient Package Insert, and Carton to
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` reflect shipping instructions, as well as for
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` assay release specification
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` S-004
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` (Changes
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` July 30, 2013
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` July 30, 2013 Revisions to the Adverse Reactions of the
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` Package Insert and corresponding sections
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` of the Patient Package Insert
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` We also acknowledge receipt of your amendment dated March 4, 2015. This submission
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` constituted a complete response to our Complete Response letter issued on February 21, 2015.
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`Reference ID: 3814364
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`

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`NDA 202514/8003
`NDA 202514/S004
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`Page 2
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`In addition to numerous editorial changes, specific revisions to the Package Insert, Patient
`Package Insert and Carton Labels are described below (additions are in underlined text and
`deletions are strikethreuglrtext).
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`S003:
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`1. 16 HOW SUPPLIED/STORAGE AND HANDLING/Storage subsection is revised as
`follows:
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`Storage
`Store refiigerated at 2 to 8°C (36 to 46°F). During shipment, ZIOPTAN may be
`maintained at temperatures up to 40°C (104°F) for a period not exceeding 2 days. Mail-
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`order prescriptions received after two days of the dispensing date noted in the prescribing
`label should not be used. Store in the original pouch. Afier the pouch is opened, the
`single-use containers may be stored in the opened foil pouch for up to 2&30 days at room
`temperature: 20 to 25°C (68 to 77°F). Protect from moisture. Write down the date you
`open the foil pouch in the space provided on the pouch. Discard any unused containers
`28$ days after first opening the pouch.
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`2. 17 PATIENT COUNSELING INFORMATION/17.1 Storage Information subsection
`is revised as follows:
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`Storage Information
`17.7
`Instruct patients on proper storage of cartons, unopened foil pouches, and opened foil
`pouches [see How Supplied/Storage and Handling (16)]. Recommended storage for
`cartons and unopened foil pouches is to store refrigerated at 2 to 8°C (36 to 46°F). After
`the pouch is opened, the single-use containers may be stored in the opened foil pouch for
`up to 28$ days at room temperature: 20 to 25°C (68 to 77°F). Protect from moisture.
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`3. PATIENT PACKAGE INSERT/How should I store ZIOPTAN? subsection is revised as
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`follows:
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`Important information for Mail—Order Patients:
`Do not use if prescription is not received within two days of dispensing date.
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`(m4)
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`Reference ID: 3814364
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`

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`NDA 202514/S003
`NDA 202514/S004
`Page 3
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`4. In the PATIENT PACKAGE INSERT/After opening the foil pouch subsection has been
`revised as follows:
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`After opening the foil pouch:
` Store the opened foil pouch at room temperature, between 68°F to 77°F (20°C to
`25°C), for up to 2830 days.
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` Throw away all unused ZIOPTAN single-use containers in the opened foil pouch
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`after 2830 days.
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`5. CARTON LABELS for the 30 and 90 count
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`a. Moved the information for mail order patients statement under the shipping
`instructions
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`b. Added statement advising patients to not use product if received beyond two days
`from dispensing date
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`S-004
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`6. In the 6 ADVERSE REACTIONS/6.2 Postmarketing Experience, a new subsection, titled
`“Respiratory disorders” is added as follows:
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`Respiratory disorders: exacerbation of asthma, dyspnea
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`7. In the PATIENT INFORMATION/What are the possible side effects of ZIOPTAN, the
`following information is added
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`Additionally, the following side effects have been reported in general use:
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` worsening of asthma
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`shortness of breath
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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-
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`upon labeling text for the Package Insert, Patient Package Insert and Cartons, which are identical
`to the labeling submitted on March 4, 2015.
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`Reference ID: 3814364
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`

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` NDA 202514/S003
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` NDA 202514/S004
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` Page 4
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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
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling text for the Package Insert and Patient
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`Package Insert, with the addition of any labeling changes in pending “Changes Being Effected”
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`(CBE) supplements, as well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“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
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`date(s).
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton labels that are identical to the ones submitted on March 4, 2015, as
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`soon as they are available, but no more than 30 days after they are printed. Please submit these
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`labels electronically according to the guidance for industry Providing Regulatory Submissions in
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`Electronic Format – Human Pharmaceutical Product Applications and Related Submissions
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`Using the eCTD Specifications (June 2008). Alternatively, you may submit 12 paper copies,
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`with 6 of the copies individually mounted on heavy-weight paper or similar material. For
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`administrative purposes, designate this submission “Final Printed Carton and Container
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`Labels for approved NDA 202514/S003. Approval of this submission by FDA is not required
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`before the labeling is used.
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`Marketing the product with FPL that is not identical to the approved labeling text may render the
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`product misbranded and an unapproved new drug.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81)
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`Reference ID: 3814364
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`

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` NDA 202514/S003
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` NDA 202514/S004
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` Page 5
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` If you have any questions, call Judit Milstein, Chief, Project Management Staff, at 301-796­
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`0763.
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`Sincerely,
`{See appended electronic signature page}
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`Wiley A. Chambers, MD
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`Deputy Director
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`Division of Transplant and Ophthalmology Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S): Package Insert
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`Patient Package Insert
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`Reference ID: 3814364
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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/
`----------------------------------------------------
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`WILEY A CHAMBERS
`09/04/2015
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`Reference ID: 3814364
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