CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`203168Orig1s000
`
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`EXCLUSIVITY SUMMARY
`
`NDA # 203168
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`SUPPL #
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`HFD #
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`Trade Name Prolensa
`
`Generic Name bromfenac ophthalmic solution, 0.07%
`
`Applicant Name Bausch & Lomb Incorporated
`
`Approval Date, If Known : April 5, 2013
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`PART I
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
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`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes"
`to one or more of the following questions about the submission.
`
`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
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` YES
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`NO
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`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`
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`505(b)(1)
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`c) Did it require the review of clinical data other than to support a safety claim or change
`in labeling related to safety? (If it required review only of bioavailability or
`bioequivalence data, answer "no.")
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` YES
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`NO
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`If your answer is "no" because you believe the study is a bioavailability study and,
`therefore, not eligible for exclusivity, EXPLAIN why it is a bioavailability study,
`including your reasons for disagreeing with any arguments made by the applicant that the
`study was not simply a bioavailability study.
`
`
`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
`
`d) Did the applicant request exclusivity?
`
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`Reference ID: 3288904
`
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`Page 1
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`

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`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
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` YES
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`NO
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`3 Years
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`e) Has pediatric exclusivity been granted for this Active Moiety?
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` YES
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`NO
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` If the answer to the above question in YES, is this approval a result of the studies submitted
`in response to the Pediatric Written Request?
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`
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY
`TO THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
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`2. Is this drug product or indication a DESI upgrade?
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` YES
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`NO
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`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE
`BLOCKS ON PAGE 8 (even if a study was required for the upgrade).
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`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drug product containing the
`same active moiety as the drug under consideration? Answer "yes" if the active moiety
`(including other esterified forms, salts, complexes, chelates or clathrates) has been previously
`approved, but this particular form of the active moiety, e.g., this particular ester or salt (including
`salts with hydrogen or coordination bonding) or other non-covalent derivative (such as a
`complex, chelate, or clathrate) has not been approved. Answer "no" if the compound requires
`metabolic conversion (other than deesterification of an esterified form of the drug) to produce an
`already approved active moiety.
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`YES
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the
`NDA #(s).
`
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`Reference ID: 3288904
`
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`Page 2
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`

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`NDA# 21664
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`NDA# 20535
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`NDA#
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`2. Combination product.
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`Xibrom/Bromday
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`Duract
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`If the product contains more than one active moiety(as defined in Part II, #1), has FDA
`previously approved an application under section 505 containing any one of the active moieties
`in the drug product? If, for example, the combination contains one never-before-approved active
`moiety and one previously approved active moiety, answer "yes." (An active moiety that is
`marketed under an OTC monograph, but that was never approved under an NDA, is considered
`not previously approved.)
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`YES
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`
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the
`NDA #(s).
`
`NDA#
`NDA#
`NDA#
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`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO
`THE SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary
`should only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
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`PART III
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of
`new clinical investigations (other than bioavailability studies) essential to the approval of the
`application and conducted or sponsored by the applicant." This section should be completed
`only if the answer to PART II, Question 1 or 2 was "yes."
`
`1. Does the application contain reports of clinical investigations? (The Agency interprets
`"clinical investigations" to mean investigations conducted on humans other than bioavailability
`studies.) If the application contains clinical investigations only by virtue of a right of reference
`to clinical investigations in another application, answer "yes," then skip to question 3(a). If the
`answer to 3(a) is "yes" for any investigation referred to in another application, do not complete
`
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`Reference ID: 3288904
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`Page 3
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`

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`remainder of summary for that investigation.
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`YES
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`NO
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`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
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`2. A clinical investigation is "essential to the approval" if the Agency could not have approved
`the application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical
`trials, such as bioavailability data, would be sufficient to provide a basis for approval as an
`ANDA or 505(b)(2) application because of what is already known about a previously approved
`product), or 2) there are published reports of studies (other than those conducted or sponsored by
`the applicant) or other publicly available data that independently would have been sufficient to
`support approval of the application, without reference to the clinical investigation submitted in
`the application.
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`(a) In light of previously approved applications, is a clinical investigation (either
`conducted by the applicant or available from some other source, including the published
`literature) necessary to support approval of the application or supplement?
`
`
` YES
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`NO
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`If "no," state the basis for your conclusion that a clinical trial is not necessary for
`approval AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`(b) Did the applicant submit a list of published studies relevant to the safety and
`effectiveness of this drug product and a statement that the publicly available data would
`not independently support approval of the application?
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` YES
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`NO
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`(1) If the answer to 2(b) is "yes," do you personally know of any reason to
`disagree with the applicant's conclusion? If not applicable, answer NO.
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` YES
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`NO
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` If yes, explain:
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`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted
`or sponsored by the applicant or other publicly available data that could
`independently demonstrate the safety and effectiveness of this drug product?
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` YES
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`NO
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`Reference ID: 3288904
`
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`Page 4
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` If yes, explain:
`
`
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`(c)
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`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical
`investigations submitted in the application that are essential to the approval:
`
`Study -S00124-ER
`Study- S00124-WR
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
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`3. In addition to being essential, investigations must be "new" to support exclusivity. The
`agency interprets "new clinical investigation" to mean an investigation that 1) has not been relied
`on by the agency to demonstrate the effectiveness of a previously approved drug for any
`indication and 2) does not duplicate the results of another investigation that was relied on by the
`agency to demonstrate the effectiveness of a previously approved drug product, i.e., does not
`redemonstrate something the agency considers to have been demonstrated in an already approved
`application.
`
`a) For each investigation identified as "essential to the approval," has the investigation
`been relied on by the agency to demonstrate the effectiveness of a previously approved
`drug product? (If the investigation was relied on only to support the safety of a
`previously approved drug, answer "no.")
`
`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`If you have answered "yes" for one or more investigations, identify each such
`investigation and the NDA in which each was relied upon:
`
`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support
`the effectiveness of a previously approved drug product?
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`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`Reference ID: 3288904
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`Page 5
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`

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`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the
`application or supplement that is essential to the approval (i.e., the investigations listed in
`#2(c), less any that are not "new"):
`
`Study-S00124-ER
`Study-S00124-WR
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored
`by" the applicant if, before or during the conduct of the investigation, 1) the applicant was the
`sponsor of the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or
`its predecessor in interest) provided substantial support for the study. Ordinarily, substantial
`support will mean providing 50 percent or more of the cost of the study.
`
`a) For each investigation identified in response to question 3(c): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`Investigation #1
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`IND # 60295
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`YES
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`Investigation #2
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`!
`!
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`! NO
`! Explain:
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`!
`!
`! NO
`! Explain:
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`IND # 60295
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`YES
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`(b) For each investigation not carried out under an IND or for which the applicant was
`not identified as the sponsor, did the applicant certify that it or the applicant's predecessor
`in interest provided substantial support for the study?
`
`
`Reference ID: 3288904
`
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`Page 6
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`Investigation #1
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`YES
`Explain:
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`Investigation #2
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`YES
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`Explain:
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`!
`!
`! NO
`! Explain:
`
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`!
`!
`! NO
`! Explain:
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`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe
`that the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to
`the drug are purchased (not just studies on the drug), the applicant may be considered to
`have sponsored or conducted the studies sponsored or conducted by its predecessor in
`interest.)
`
`
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`
`
`YES
`
`
`
`NO
`
`If yes, explain:
`
`=================================================================
`
`Name of person completing form: Michael Puglisi
`Title: Regulatory Project Manager
`Date: April 4, 2013
`
`Name of Division Director signing form: Renata Albrecht, MD
`Title: Director, Division of Transplant and Ophthalmology Products
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
`
`
`Reference ID: 3288904
`
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`Page 7
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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/
`----------------------------------------------------
`MICHAEL J PUGLISI
`04/05/2013
`
`RENATA ALBRECHT
`04/05/2013
`
`Reference ID: 3288904
`
`

`

`Bromfenac Ophthalmic Solution 0.07%
`1.3.3 Debarment Certification
`
`
`[STA Pharmaceuticals, Inc.
`NDA 203l68
`
`- .
`
`)
`
`,
`
`Pharmaceuticals;
`
`50 Technology
`
`Irvine CA. 92618
`
`949) 3’88~5OD-’)
`
`tax 949) 75813010
`
`.
`
`3
`
`5
`
`Debarment Certification for NDA 203168 for
`
`Bromfenac Ophthalmic Solution 0.07%
`
`lSTA Pharmaceuticals®, Inc. hereby certifies that it did not and will not use in
`any capacity the services of any person or entity debarred under Section 306 of
`the Federal Food, Drug, and Cosmetic Act in connection with this application.
`
`www Isfawsron com
`
`Signed:
`
`
`
`Marvin I. Garrett
`Vice President
`
`Regulatory Affairs, Quality Assurance
`& Compliance
`
`
`
`Date
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`Page 1 of 1
`
`

`

`ACTION PACKAGE CHECKLIST
`
`
`
`NDA # 203168
`BLA #
`
`NDA Supplement #
`BLA Supplement #
`
`Proprietary Name: Prolensa
`Established/Proper Name: bromfenac sodium
`Dosage Form:
`ophthalmic solution
`
`RPM: Michael Puglisi
`NDAs and NDA Efficacy Supplements:
`
`
`_
`
`IfNDA, Efficacy Supplement Type.
`
`
`
`
`Applicant: Bausch & Lomb, Inc.
`Agent for Applicant (if applicable):
`
`Division: DTOP
`
`50$an Ogigina! NDAs and §0§1m12) NDA supplemepts:
`
`
`
`(A supplement can be either a (b)(l) or a (b)(2)
`regardless of whether the original NDA was a (b)(l)
`or a (b)(2). Consult page 1 of the 505(b)(2)
`Assessment or the Appendix to this Action Package
`Checklist.)
`
`NDA Application Type: E’SOS(b)(1) C] 505(b)(2) Listed drug(s) relied upon for approval (include NDA #(s) and drug
`Efficacy Supplement:
`E] 505(b)(1) [j 505(b)(2)
`name(s)):
`
`
`
`Provide a brief explanation of how this product is different from the listed
`
`
`drug.
`
`
`
`This application does not reply upon a listed drug.
`
`
`This application relies on literature.
`
`
`This application relies on a final OTC monograph.
`This application relies on (explain)
`‘
`
`or
`F ALL (b)(2) applicati ns, two months prior
`. '
`..
`s
`re '
`
`to EVERY actiona
`ft he
`
`
`
`
`
`
`
`
`On the day of approval, check the Orange Book again for any new
`patents or pediatric exclusivity.
` C] No changes D Updated Date of check:
`
`
`
`If pediatric exclusivity has been granted or the pediatric information in
`the labeling of the listed drug changed, determine whether pediatric
`information needs to be added to or deleted from the labeling of this
`drug.
`
`
`
`
`
`
`
`
`
`
`e Application Information Section is (only) a checklist. The Contents of Action Package Section (beginning on page 5) lists
`d documents to be included in the Action Package.
`.
`2 For resubmissions, (b)(2) applications must be cleared before the action, but it is not necessary to resubmit the drafi 505(b)(2)
`Assessment to CDER 0ND 10 unless the Assessment has been substantively revised (e.g., nrew listed drug, patent certification
`revised).
`Reference ID: 32971 13
`Reference ID: 3297113
`
`Version: 1/27/12
`
`

`

`NDA 203168
`
`Page 2
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`If accelerated approval or approval based on efficacy studies in animals, were promotional
`laterials received?
`_
`Note: Promotional materials to be used within 120 days after approval must have been
`submitted (for exceptions, see
`ht_tp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatogInformation/Guida
`nces/ucm069965. .d . If not submitted, eXolain
`
`El Received
`
` Application Characteristics 3
`
`1:] Priority
`IX] Standard
`Review priority:
`Chemical classification (new NDAs only):
`
`Fast Track
`Rolling Review
`Orphan drug designation
`
`[:1 Rx-to-OTC full switch
`E] Rx—to-OTC partial switch
`E] Direct-to-OTC
`
`NDAs: Subpart H
`E] Accelerated approval (21 CFR 314.510)
`B Restricted distribution (21 CFR 314.520)
`Subpart I
`E] Approval based on animal studies
`
`BLAs: Subpart E
`E Accelerated approval (21 CFR 601.41)
`Restricted distribution (21 CFR 601.42)
`Subpart H
`U Approval based on animal studies
`
`'
`E Submitted inresponse to a PMR
`Submitted in response to a PMC
`[:1 Submitted in response to a Pediatric Written Request
`
`REMS:
`
`MedGuide
`Communication Plan
`ETASU
`MedGuide w/o REMS
`
`REMS not required
`
`Tomments:
`
`V
`I
`0:; BLAs only: Ensure RMS-BLA Product Information Sheetfor TBP and RMS-BLA Facility
`Information Sheetfor TBP have been completed and forwarded to OPI/OBI/DRM (Vicky D Yes, dates
`Carter
`.
`'2' BLAs only: Is the product subject to official FDA lot release per 21 . CFR 610.2
`(approvals only),
`'
`
`Yes
`
`I] No
`
`, D
`
`'
`
`
`
`
`
`
`0
`
`Indicate what types (if any) of information dissemination are anticipated
`
`FDA Talk Paper
`CDER Q&As
`
` I
`
`‘ nswer all questions in all sections in relation to the pending application, i.e., ifthe pending application is an NDA or BLA
`llement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA. For
`_.imp1e, ifthe application is a pending BLA supplement, then a new RMS—BLA Product Information Sheetfor TBP must be
`completed.
`
`Version: 1/27/12
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`

`

`NDA 203 168
`
`Page 3
`
`If Ixclusivity
`
`Is approval ofthis application blocked by any type ofexclusivity?
`
`o NDAs and BLAs: Is there existing orphan drug exclusivity for the“same”
`E No
`drug or biologic for the proposed indication(s)? Refer to 21 CFR
`If, yes, NDA/BLA #
`3I 6.3(b) (13) for the definition of “same drug ”for an orphan drug (i. e.,
`active moiety). This definition is NOT the same as that usedfor NDA
`date exclusivity expires:
`
`chemical classifcation
`‘
`
`0
`
`(b)(2) NDAs only: Is there remaining 5-year exclusivity that would bar
`If yes, NDA #
`effective approval ofa 505(b)(2) application)? (Note that, even ifexclusivzty
`remains, the application may be tentatively approved ifit is otherwise ready
`exclusivity ex ires‘
`for approval)
`p
`'
`
`0
`(b)(2) NDAs only: Is there remaining3-year exclusivity that would bar
`effective approval ofa 505(b)(2) application? (Note that, even ifexclusivity
`If yes, NDA #
`and date
`remains, the application may be tentatively approved zfzt IS otherwzse ready
`exclusivity ex ireS'
`for approval.)
`p
`'
`
`(b)(2) NDAs only: Is there remaining6-month pediatric exclusivity that
`o
`If es NDA #
`would bar effective approval of a 505(b)(2) application? (Note that, even if
`eleusivity ex ireS'
`exclusivity remains, the application may be tentatively approved ifit is
`otherwise readyfor approval.)
`p
`'
`
`0 NDAs only: Is this a single enantiomerthat fallsunder the 10-year approval
`limitation of 505(u)? (Note that, even ifthe I 0——year approval limitation
`period has not expired, the application may be tentatively approved ifit is
`otherwise readyfor approval.)
`
`
`
`and date
`
`and date
`
`If yes, NDA #
`
`and date 10—
`
`year limitation expires:
` D N/A (no paragraph IV certification)
`
`°:' Patent Information (NDAs only)
`
`i
`
`.
`
`'1
`
`.
`
`0
`
`0
`
`Verified
`Patent Information:
`Verlfy that formFDA—3542a was subnntted for patents that cla1m the drug for
`Not applicable because drug is
`whlch approval is sought.
`If the drug 1s an old antibiotlc, Sklp the Patent
`.
`.
`.
`an old ant1b10t1c.
`
`Certification questions.
`.
`21 CFR 314.50(i)(l)(i)(A)
`Patent Certification [505(b)(2) applications]:
`[J Verified
`Verify that a certification was submitted for each patent for the listed drug(s) in
`the Orange Book and identify the type of certification submitted for each patent.
`21 CFR 314.50(i)(1)
`
`__.__.............................................................................................D... an..- E1................................
`0
`[505(b)(2) applications] Ifthe application includes a paragraph III certification,
`C] No paragraph 111 certification
`it cannot be approved until the date that the patent to which the certification
`pertains expires (but may be tentatively approved if it is otherwise ready for
`Date patent will expire
`
`approval).
`
`0
`
`[505(b)(2) applications] For each paragraph IV certification, verify that the
`applicant notified the NDA holder and patent owner(s) of its certification that the
`patent(s) is invalid, unenforceable, or will not be infiinged (review
`documentation of notification by applicant and documentation of receipt of
`notice by patent owner and NDA holder). (Ifthe application does not include
`any paragraph IV certifications, mark “N/A ” and skip to the next section below
`(Summary Reviews)).
`
`[3 Verified
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`Version: 1/27/ 12
`
`

`

`NDA 203168
`
`Page 4
`
`0
`
`[505(b)(2) applications] For each paragraph IV certification, based on the
`questions below, determine whether a 30-month stay of approval is in effect due
`to patent infringement litigation.
`
`Answer the following questions for each paragraph IV certification:
`
`(1) Have 45 days passed since the patent owner’s receipt of the applicant’s
`notice of certification?
`
`[:1 Yes
`
`'DNo
`
`(Note: The date that the patent owner received the applicant’s notice of
`certification can be determined by checking the application. The applicant
`is required to amend its 505(b)(2) application to include documentation of
`this date (e.g., copy of return receipt or letter from recipient
`acknowledging its receipt of the notice) (see 21 CFR 314.52(e))).
`
`If “Yes, " skip to question (4) below. If “No, ” continue with question (2).
`
`(2) Has the patent owner (or NDA holder, if it is an exclusive patent licensee)
`submitted a written waiver of its right to file a legal action for patent
`infiingement afier receiving the applicant’s notice of certification, as
`provided for by 21 CFR 314.107(f)(3)?
`
`E] Yes
`
`[I No
`
`If “Yes, ” there is no stay ofapproval based on this certification. Analyze the next
`paragraph IV certification in the application, ifany. Ifthere are no other
`paragraph IV certifications, skip the rest ofthe patent questions.
`
`If “No, ” continue with question (3).
`
`(3) Has the patent owner, its representative, or the exclusive patent licensee
`filed a lawsuit for patent infringement against the applicant?
`
`D Yes
`
`DNO
`
`(Note: This can be determined by confirming whether the Division has
`received a written notice from the (b)(2) applicant (or the patent owner or
`its representative) stating that a legal action was filed within 45 days of
`receipt of its notice of certification. The applicant is required to notify the
`Division in writing whenever an action has been filed within this 45-day
`period (see 21 CFR 314.107(f)(2))).
`
`If “No, ” the patent owner (or NDA holder, ifit is an exclusive patent licensee)
`has until the expiration ofthe 45-day period described in question (1) to waive
`its right to bring a patent infringement action or to bring such an action. After
`the 45-day period expires, continue with question (4) below.
`
`(4) Did the patent owner (or NDA holder, if it is an exclusive patent licensee)
`submit a written waiver of its right to file a legal action for patent
`infiingement within the 45-day period described in question (1), as
`provided for by 21 CFR 314.107(t)(3)?
`
`E] Yes
`
`DNo
`
`If “Yes, " there is no stay ofapproval based on this certification. Analyze the next
`paragraph IV certification in the application, ifany. Ifthere are no other
`paragraph IV certifications, skip to the next section below (Summary Reviews).
`
`If “No, ” continue with question (5).
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`Version: 1/27/12
`
`

`

`NDA 203 168
`
`Page 5
`
`(5) Did the patent owner, its representative, or the exclusive patent licensee
`bring suit against the (b)(2) applicant for patent infiingement within 45
`days of the patent owner’s receipt of the applicant’s notice of
`certification?
`
`(Note: This can be determined by confirming whether the Division has
`received a written notice from the (b)(2) applicant (or the patent owner or
`its representative) stating that a legal action was filed within 45 days of
`receipt of its notice of certification. The applicant is required to notify the
`Division in writing whenever an action has been filed within this 45-day
`period (see 21 CFR 314.107(i)(2)). If no written notice appears in the
`NDA file, confirm with the applicant whether a lawsuit was commenced
`within the 45-day period).
`
`If “No, ” there is no stay ofapproval based on this certification. Analyze the
`next paragraph IV certification in the application, ifany. Ifthere are no other
`paragraph IV certifications, skip to the next section below (Summary
`Reviews).
`
`If “Yes, " a stay ofapproval may be in efi’ect. T0 determine ifa 30—month stay
`is in eflect, consult with the 0ND ADRA and attach a summary ofthe
`response.
`
`'
`
`Copy of this Action Package Checklist4
`
`'3' List of officers/employees who particlpated 1n the de01s1on to approve thJS application and
`consented to_be identified on this list (approvals only)
`
` In—cluded Submitted 6/6/12
`
`
`
`
`
`Included — Submitted 4/3/13
`
`
`Example ofclass labeling, if applicable
`
`4 Fill in blanks with dates of reviews, letters, etc.
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`Version: 1/27/12
`
`

`

`NDA 203 168
`
`Page 6
`
`\
`
`tiedication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right offirst page ofeach piece)
`
`
`
` I Medication Guide
`I Patient Package Insert
`
`
`I Instructions for Use
`
`
`
`I Device Labeling
`
`
`
`
`
`
`
`
`
`
`0 Most-recent drafi labeling
`
`
`'2' Proprietary Name
`
`11/9/12
`0 Acceptability/non—acceptability letter(s) (indicate date(s))
`
`
`
`
`11/7/12, 3/4/13
`indicate date s
`
`
`K4 RPM 8/20/13
`
`
`
`
`
`
`
`
`
`
`
`'3" Labeling reviews (indicate dates ofreviews and meetings)
`
`,DMEPA 2/8/13
`DMPP/PLT (DRISK)
`ODPD (DDMAC) 3/20/13
`SEALD
`
`
`
`ma
`t
`Doc
`
`'3’ Administrative Reviews (e.g., RPMFiling Review /Memo ofFiling Meeting) (indicate
`V 8/20/12 I
`1
`
`
`date ofeach review)
`Nota(b)(2)
`All NDA (b)(2) Actions: Date each action cleared by (b)(2) Clearance Cmte
`
`
`NDA b 2 VAuro-vals Onl
`:_ 505 . 2 Assessment
`indicate date
`
`g CSS
`Other reviews
`
`
`
`
`
` 0
`
`
`This application is on the AIP
`
`
`
`o
`If yes, Center Director’s Exception for Review memo (indicate date)
`
`o
`If yes, OC clearance for approval (indicate date ofclearance
`El Not an AP action
`.
`.
`
`communication)
`
`Pediatrics (approvals only)
`
`
`0 Date reviewed by PeRC
`er PREA
`If PeRC review not necessary, explain: Does not tn”
`Pediatric Page/Record (approvals only, must be reviewed by PERC before
`
`
`znalized
`
`
`
`E] Included
`
`
`
`
`E Verified, statement is
`acceptable
`
`
`
`
`
`0
`
`0 v
`
`
`
`5
`
`4' Debarment certification (original applications only): verified that qualifying language was
`not used in certification and that certifications from foreign applicants are cosigned by
`US. agent (include certification)
`Outgoing communicatiOns (letters, including response to FDRR (do not include previous
`action letters in this tab , emails, axes, telecons
`7
`
`
`5 Filing reviews for scientific disciplines should be filed behind the respective discipline tab.
`
`Version: 1/27/ 12
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`Included
`
`

`

`NDA 203 168
`
`Page 7
`
`linutes ofMeetings
`
`
`
`
`Ifnot the first review cycle, any end-of--review meeting (indicate date ofmtg)
`
`
`
`
`
`
`
`
`
`
`
`
`
`0:0
`
`
`1 3/22/13
`
`
`0
`Social scientist review(s) (if OTC drug) (indicate datefor each review)
`
`
`
`Financial Disclosure reviews(s) (gliocation/date ifaddressed1n another review
`In 3/22/13, Clinical Review
`If no financial disclosure information was required, check here E] and include a
`
`
`
`review/memo explaining why not (indicate date ofreview/memo)
`’
`
`‘3 Clinical reviews from immunology andother clinical areas/divisions/Centers (indicate
`E None
`date ofeach review)
`'3 Controlled Substance Staffreview(s).and Scheduling Recommendation (indicate date of
`each review)
`’2' Risk Management
`I REMS Documents and Supporting Statement (indicate date(s) ofsubmission(s))
`0
`REMS Memo(s) and letter(s) (indicate date(s))
`0
`Risk management review(s) and recommendations (including those by OSE and
`CSS) (indicate date ofeach review and indicate location/date ifincorporated
`into another review)
`
`Not a
`pp
`
`licable
`
`
`
`
`
`
`
`None
`
`
`
`
`
`
`
`
`
`
`‘3' OSI Clinical Inspection Review Summary(ies) (include copies ofOSI letters to
`investigators)
`
`Included
`
`‘
`
`
`
`6 Filing reviews should be filed with the discipline reviews.
`
`Version: 1/27/12
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`

`

`NDA 203168
`
`Page 8
`
`I-
`
`‘v
`
`Clinical Microbiology Review(s) (indicate datefor each review)
`
`
`
`
`
`
`Clinical Pharmacology Team Leader Review(s) (indicate datefor each review)
`
`
`
`
`
`
`
`revzew .
`
`Review(s) by other disciplines/divisions/Centers requested by P/T reviewer (indicate date 8 IiNvone
`foreach review). .
`‘
`,.
`,
`,
`,
`,
`,.
`
`
`
`
`
`
`
`
` D None
`
`7/20/12, 7/26/12,
`Product quality review(s) including ONDQA biopharmaceutics reviews (indicate
`2/26/13, 4/4/13
`
`datefor each review)
`
`
`
`
`'3' Microbiology Reviews
`
`
`E NDAs: Microbiology reviews (sterility & pyrogenicity) (OPS/NDMS) (indicate
`
`date ofeach review)
`
`
`C] BLAs: Sterility assurance, microbiology, facilities reviews
`
`(OMPQ/MAPCB/BMT) (indicate date ofeach review)
`
`{0 Reviews by other disciplines/divisions/Centers requested by CMC/quality reviewer
`(indicate date ofeach review)
`
`D Not needed
`1/22/ 13
`
`E None
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`Vasion: 1/27/12
`
`

`

`NBA 203 168
`
`Page 9
`
`Environmental Assessment (check one) (original and supplemental applications)
`E Categorical Exclusion (indicate review date)(all original applications and
`all efficacy supplements that couldincrease the patientpopulation)
`
`In 2/26/13, Product Quality
`
`'
`
`date) (original and supplemental BLAs)
`
`'3' Facilities Review/Inspection
`
`Date completedt 7/27/12
`‘
`i
`E Acce table
`I: NDAs: Facilities inspections (include EER printout) (date completed must be
`'3 Withlliold recommendation
`within 2 years ofaction date) (only original NDAS and supplements that include
`
`a newfaczlzty or'a change that aflects the rnanufacturing sites7) -------------------------- A QNOLQRpliQablfi
`
`
`Date completed:
`__ Acceptable
`Withhold recommendation
`
`I: BLAs: TB-EER (date ofmost recent TB-EER must be within 30 days ofaction
`
`.3 NDAs: Methods Validation (check box only, do not include documents)
`
`[3, Completed
`
`B 2231;333:1116ted
`
`8 Not needed (per review)
`
`7 Le, a new facility or a change in the facility, or a change in the manufacturing process in a way that impacts the Quality
`Management Systems of the facility.
`
`Version: 1/27/12
`
`Reference ID: 3297113
`Reference ID: 3297113
`
`

`

`NDA 203168
`Page 1
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Antimicrobial Products
`Division of Transplant and Ophthalmology
`Products
`
`Information Request
`
`DATE: March 4, 2013
`
`To: B&L Pharmaceuticals, Inc.
`Attention: Paul Nowacki
`e-mail: E paul.nowacki@bausch.com
`
`From: Michael Puglisi, Regulatory Project Manager
`e-mail: Michael.puglisi@fda hhs.gov
`Phone Number: 301-796-0791
`
`Phone Number: 949-789-3109
`Subject: Clinical/Stats Comments/Request for NDA 203168
`
`Total no. of pages including cover: 2
`
`Comments:
`
`Hi Paul,
`
`Attached please find an information request from our clinical reviewer for NDA 203168. Please
`confirm you have received this request and let me know if you have any questions about it.
`Thanks.
`
`Mike
`
`THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS
`ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL,
`AND PROTECTED FROM DISCLOSURE UNDER APPLICABLE LAW.
`
`If you are not the addressee, or a person authorized to deliver this document to the addressee, you
`are hereby notified that any review, disclosure, dissemination, copying, or other action based on the
`content of this communication is not authorized. If you have received this document in error, please
`notify us immediately by telephone at 301-796-1600. Thank you.
`
`Reference ID: 3270734
`
`

`

`NDA 20