`
`Approval Package for:
`
`
`
`APPLICATION NUMBER:
`
`203168Orig1s000
`
`Prolensa Ophthalmic Solution 0.07%
`
`Bromfenac Ophthalmic Solution
`
`Bausch & Lomb, Inc.
`
`04/05/2013
`
`Trade Name:
`
`Generic Name:
`
`Sponsor:
`
`Approval Date:
`
`Indications:
`
` Treatment of Postoperative Inflammation and
`Reduction of Ocular Pain in Patients Who Have
`Undergone Cataract Surgery.
`
`
`
`Page 1 of 7
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`SENJU EXHIBIT 2152
`LUPIN v. SENJU
`IPR2015-01097
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`203168Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
`
`X
`X
`X
`X
`X
`X
`
`X
`X
`X
`X
`X
`
`X
`X
`
`Page 2 of 7
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`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`203168Orig1s000
`
`APPROVAL LETTER
`
`
`
`Page 3 of 7
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`NDA 203168
`
`Bausch & Lomb, Incorporated
`Attention: Paul Nowacki
`Director, Regulatory Affairs
`50 Technology Drive
`Irvine, CA 92618
`
`Dear Mr. Nowacki:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`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%.
`
`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.
`
`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.
`
`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. 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.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`Reference ID: 3288918
`
`Page 4 of 7
`
`
`
`NDA 203168
`Page 2
`
`CARTON AND IMMEDIATE-CONTAINER LABELS
`
`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.
`
`Marketing the product with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new drug.
`
`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.
`
`MARKET PACKAGE
`
`Please submit one market package of the drug product when it is available to the following
`address:
`
`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
`Use zip code 20903 if shipping via United States Postal Service (USPS).
`Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL, FedEx).
`
`
`
`PEDIATRIC ASSESSMENT
`
`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.
`
`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.
`
`Reference ID: 3288918
`
`Page 5 of 7
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`
`
`NDA 203168
`Page 3
`
`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
`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. For instruction on completing the Form FDA 2253, see page 2 of the Form. 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 Michael Puglisi, Regulatory Project Manager, at (301) 796-0791.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Renata Albrecht, MD
`Director
`Division of Transplant and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`
`
`
`Enclosures:
`Content of Labeling
`Carton and Container Labeling
`
`Reference ID: 3288918
`
`Page 6 of 7
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`04/05/2013
`
`Reference ID: 3288918
`
`Page 7 of 7