DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`NDA 206276
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`Alcon Research, Ltd.
`Attention: Naj Sharif, PhD
`Global Regulatory Project Manager
`
`6201 South Freeway
`Mail Stop: TC-45
`Fort Worth, TX 76134-2099
`
`Dear Dr. Shariff:
`
`Please refer to your New Drug Application (NDA) dated and received, July 30, 2014, submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Pazeo
`(olopatadine hydrochloride ophthalmic solution) 0.7%.
`
`We acknowledge receipt of your amendments dated:
`
`August 5, 2014
`August 25, 2014
`August 28, 2014
`September 4, 2014
`October 3, 2014
`
`October 6, 2014
`October 15, 2014
`October 17, 2014
`October 23, 2014
`October 29, 2014
`
`December 4, 2014
`December 17, 2014
`January 22, 2015
`January 29, 2015
`
`This new drug application provides for the use of Pazeo (olopatadine hydrochloride ophthalmic
`solution) 0.7% for the treatment of ocular itching associated with allergic conjunctivitis.
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed -upon labeling text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`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 .
`
`Reference ID: 3694617
`
`

`

`Content of labeling must be identical to the enclosed labeling text for the package insert.
`Information on submitting SPL files using eLIST may be found in the guidance for industry SPL
`
`Standard for Content of Labeling Technical Qs and As, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels received January 29, 2015, as soon as they are available,
`but no more than 30 days after they are printed. Please submit these labels electronically
`
`according to the guidance for industry Providing Regulatory Submissions in Electronic Format –
`
`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications (June 2008). Alternatively, you may submit 12 paper copies, with 6 of the copies
`individually mounted on heavy-weight paper or similar material. For administrative purposes,
`designate this submission “Final Printed Carton and Container Labels for approved NDA
`206276.” Approval of this submission by FDA is not required before the labeling is used.
`
`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`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.
`
`We are waiving the pediatric studies requirement for ages 0 to < 2 years because studies are
`impossible or highly impracticable. This is because allergic conjunctivitis cannot be reliably
`
`diagnosed below the age of 2 and therefore the number of potential pediatric patients with the
`condition is very small.
`
`We note that you have fulfilled the pediatric studies requirement for ages 2 to 16 years for this
`application.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`
`Reference ID: 3694617
`
`

`

`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. Form 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.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Ms. Lois Almoza, Regulatory Health Project Manager, at
`(301) 796-1600.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Renata Albrecht, M.D.
`Director
`Division of Transplant and Ophthalmology
`Products
`Office of Antimicrobial Products
`Office of New Drugs
`Center for Drug Evaluation and Research
`
`Enclosure(s):
`Content of Labeling
`Carton and Container Labeling
`
`Reference ID: 3694617
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RENATA ALBRECHT
`01/30/2015
`
`Reference ID: 3694617
`
`