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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 203168
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`Food and Drug Administration
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`Silver Spring MD 20993
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`NDA APPROVAL
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`Bausch & Lomb, Incorporated
`Attention: Paul Nowacki
`Director, Regulatory Affairs
`50 Technology Drive
`Irvine, CA 92618
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`Dear Mr. Nowacki:
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`Please refer to your New Drug Application (NDA) dated June 6, 2012, received June 7, 2012,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Prolensa
`(bromfenac ophthalmic solution) 0.07%.
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`We acknowledge receipt of your amendments dated August 20 and 31, September 8, 12, and 20,
`October 9, November 16, and December 19 and 20, 2012, and March 12, 18, and April 3, 2013.
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`This new drug application provides for the use of Prolensa (bromfenac ophthalmic solution)
`0.07% for the treatment of postoperative inflammation and reduction of ocular pain in patients
`who have undergone cataract surgery.
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`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.
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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
`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 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.
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`The SPL will be accessible via publicly available labeling repositories.
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`Reference ID: 3288918
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`NDA 203168
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`Page 2
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` CARTON AND IMMEDIATE-CONTAINER LABELS
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`Submit final printed carton and immediate-container labels that are identical to the enclosed
`carton and immediate-container labels, 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 203168.” Approval of this
`submission by FDA is not required 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
`product misbranded and an unapproved new drug.
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`With the next scheduled printing, the cartons should be revised to include a more precise
`description of the active (i.e., bromfenac sodium sesquihydrate 0.0805%) consistent with the
`package insert.
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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:
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`Michael Puglisi
`Food and Drug Administration
`Center for Drug Evaluation and Research
`White Oak Building 22, Room: 6162
`10903 New Hampshire Avenue
`Silver Spring, Maryland
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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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`PEDIATRIC ASSESSMENT
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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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`Because your application does not include a new active ingredient, new indication, new dosage
`form, new dosing regimen, or new route of administration, this requirement is inapplicable.
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`Reference ID: 3288918
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`NDA 203168
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`Page 3
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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, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`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. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more
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`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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`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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`If you have any questions, call Michael Puglisi, Regulatory Project Manager, at (301) 796-0791.
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`Sincerely,
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` {See appended electronic signature page}
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`Renata Albrecht, MD
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` Director
`Division of Transplant and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Enclosures:
`Content of Labeling
`Carton and Container Labeling
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`Reference ID: 3288918
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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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`RENATA ALBRECHT
`04/05/2013
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`Reference ID: 3288918
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