CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`204654Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`
`
`EXCLUSIVITY SUMMARY
`
`
`
`
`
`SUPPL #
`
` 2013
`
`
`
`
`
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`
`
`
`
`
`
`HFD #
`
`
`
`
`
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`
`NDA # 204654
`
`Trade Name: Lo Minastrin Fe
`
`Generic Name: norethindrone acetate and ethinyl estradiol chewable tablets and ethinyl estradiol
`tablets and ferrous fumarate tablets
`
`
`
`
`
`Applicant Name: Warner Chilcott Company, LLC
`
`Approval Date, If Known: July
`
`PART I
`
`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?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`
`
`505(b)(1)
`
`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.")
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`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:
`
`
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`
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`
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`Reference ID: 3346339
`
`Page 1
`
`(b) (4)
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`

`

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`
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`d) Did the applicant request exclusivity?
`
`
`
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`e) Has pediatric exclusivity been granted for this Active Moiety?
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
` 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?
`
`
`
`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
`
`
`2. Is this drug product or indication a DESI upgrade?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`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).
`
`
`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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`Reference ID: 3346339
`
`Page 2
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`

`

`
`
`NDA#
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`
`NDA#
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`
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`NDA#
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`
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`
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`Lo Loestrin Fe
`
`
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`
`
`Reference ID: 3346339
`
`Page 3
`
`
`
`
`
`2. Combination product.
`
`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.)
`
`YES
`
`
`
`NO
`
`
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`NDA# 022501
`NDA#
`
`NDA#
`
`
`
`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.
`
`
`PART III
`
`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 remainder of
`summary for that investigation.
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`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.
`
`
`(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
`
`
`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:
`
`
`
`NO
`
`
`
`
`
`
`
`
`
`(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?
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`(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.
`
`
`
`
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
` If yes, explain:
`
`
`
`
`
`(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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`Reference ID: 3346339
`
`Page 4
`
`

`

`
` If yes, explain:
`
`
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`
`
`
`(c)
`
`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 PR-10007, an oral irritation study
`
`
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`
`
`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
`
`Investigation #2
`
`
`
`
`
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`
`
`
`
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`
`
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`
`
`YES
`
`YES
`
`
`
`
`
`NO
`
`NO
`
`
`
`
`
`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`Study PR-10007, an oral irritation study was also used in the approval of
`NDA 203667 (Minastrin 24 Fe)
`
`
`
`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?
`
`
`
`
`Investigation #1
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`
`
`Reference ID: 3346339
`
`Page 5
`
`

`

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`
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`Investigation #2
`
`
`
`
`
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`
`
`
`YES
`
`
`
`NO
`
`
`
`
`
`
`
`
`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`NDA 203667 (Minastrin 24 Fe)
`
`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"):
`
`
`
`
`
`
`
`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.
`
`
`Investigation #1
`
`
`
`IND #
`
`
`
`
`
`
`
`
`
`YES
`
`
`Investigation #2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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?
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`YES
`
`
`
`
`
`
`IND #
`
`
`
`
`
`
`
`
`
`
`
`
`
`(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: 3346339
`
`Page 6
`
`

`

`
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`
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`
`
`Investigation #1
`
`
`
`
`
`YES
`Explain:
`
`
`
`Investigation #2
`
`
`YES
`Explain:
`
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`
`
`(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.)
`
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`If yes, explain:
`
`
`
`
`
`
`
`=================================================================
`
`
`
` Name of person completing form: Pamela Lucarelli
`Title: Regulatory Health Project Manager
`Date: July 16, 2013
`
`Name of Office/Division Director signing form: Audrey Gassman, M.D.
`Title: Deputy Director, Division of Bone, Reproductive, and Urologic Products
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
`
`
`
`Reference ID: 3346339
`
`Page 7
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PAMELA LUCARELLI
`07/24/2013
`
`AUDREY L GASSMAN
`07/24/2013
`
`Reference ID: 3346339
`
`

`

`WARNER CHIL CO TT
`1.3. Administrative Information
`
`3.
`
`DEBARMENT CERTIFICATION
`
`I hereby certify that Warner Chilcott Company, LLC did not and will not use in any capacity the
`services of any person debarred under section 306(a) and (b) of the Federal Food, Drug and
`Cosmetic Act in connection with this New Drug Application.
`
`
`
`Alvin Howard
`
`Date
`
`Senior Vice President, Regulatory Affairs
`Warner Chilcott (US), LLC on behalf of
`Wamer Chilcott Company, LLC
`
`‘
`
`CONFIDENTIAL
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`SIGNATURES
`
`
`
`
`DateSigned by Justification
`
`
`
`Regulatory Affairs Approval
`Sep-24—2012, 17:49:32 PM, UTC
`Alvin Howard
`
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`ACTION PACKAGE CHECKLIS
`
`
`APPLICATION INFORMATION1
`
`
`
`
`NDA # 204654
`BLA #
`
`NDA Supplement #
`BLA Supplement #
`
`If NDA, Efficacy Supplement Type:
`
`
`
` Products
`
`Proprietary Name: Lo Minastrin Fe
`Established/Proper Name: norethindrone acetate and ethinyl
`Applicant: Warner Chilcott Company, LLC
`estradiol chewable tablets and ethinyl estradiol tablets and ferrous
`Agent for Applicant (if applicable):
`fumarate tablets
`
`Dosage Form:
`tablets
`
`RPM: Pamela Lucarelli
`
`Division: Division of Bone, Reproductive, and Urologic
`
`NDAs and NDA Efficacy Supplements:
`
`5051b212) Original NDAs and SOSQbMZ) NDA supplements:
`
`
`
`
`NDA Application Type: X 505(b)(l) _ 505(b)(2) Listed drug(s) relied upon for approval (include NDA #(s) and drug
`
`
`
`
`Efficacy Supplement:
`505(b)( l)
`505(b)(2)
`name(s)):
`
`(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.)
`
`
`
`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.
`I: This application relies on (explain)
`
`
`
`
`lications. two months orior to EVERY actionz
`a )
`For ALL b
`review the information in the 505(b)(2) Assessment and submit the
`draft2 to CDER 0ND 10 for clearance. Finalize the 505(b)(2)
`Assessment at the time of the approval action.
`
`On the day of approval, check the Orange Book again for any new
`patents or pediatric exclusivity.
`
`
`
`
`
`
`No changes E 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.
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Previous actions (specify type and (lafefor each action. taken)
`
`Proposed action
`User Fee Goal Date is July 28, 2013
`
`
`
`I The Application Information Section is (only) a checklist. The Contents of Action Package Section (beginning on page 5) lists
`3 documents to be included in the Action Package.
`For resubmissions, (b)(2) applications must be cleared before the action, but it is not necessary to resubmit the draft 505(b)(2)
`Assessment to CDER OND IO unless the Assessment has been substantively revised (e.g., nrew listed drug, patent certification
`revised).
`
`Version: 6/14/13
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`
`
`
`
`
`Is the product subject to official FDA lot release per 21 CFR 610.2
`‘1' BLAs only:
`(approvals only)
`
`‘2' Public communications (approvals only)
`
`0
`
`0
`
`0
`
`Office of Executive Programs (OEP) liaison has been notified of action
`
`Press Office notified of action (by OEP)
`
`Indicate what types (if any) of information dissemination are anticipated
`
`
`
`
`
`__ Yes
`
`E] No
`
`X Yes D No
`
`
`
`
`X Yes D No
`
`‘
`: None
`
`HHS Press Release
`
`
`
`FDA Talk Paper
`CDER Q&As
`Other
`
`NDA 204654
`
`Page 2
`
`
`
`[—69
`
`If accelerated approval or approval based 011 efficacy studies in animals, were promotional
`materials received?
`
`
`
`
`
`
`Note: Promotional materials to be used within 120 days after approval must have been
`
` Received
`
`
`submitted (for exceptions, see
`
`
`http://www.fda.gov/downloads/Dru(vs/GuidanceComplianceRegulatorvliiformation/Guida
`
`nces/ucmO69965.pdf). If not submitted, explain
`
`
`0
`
`N Application Characteristics 3
`
`l:| Priority
`[Z] Standard
`Review priority:
`Chemical classification (new NDAs only):
`
`
`_ Fast Track
`
`_ Rolling Review
`:I Orphan drug designation
`
`
`
`\lDAs: Subpart H
`E Accelerated approval (21 CFR 314.510)
`1: Restricted distribution (21 CFR 314.520)
`Subpart l
`E Approval based on animal studies
`
`
`
`
`
`[— Rx-to-OTC full switch
`Rx-to-OTC partial switch
`Direct-to-OTC
`
`
`
`
`
`
`BLAs: SubpartE
`
`
`
`Accelerated approval (21 CFR 601.41)
`_ Restricted distribution (21 CFR 601.42)
`
`Suapart H
`Approval based on animal studies
`
`
`
`
`
`
`.— Submitted in response to a PMR
`
`
`Submitted in response to a PMC
`_ Submitted in response to a Pediatric Written Request
`
`
`
`
`
`REMS:
`
`
`
`
`
`
`
`MedGuide
`Communication Plan
`ETASU
`E MedGuide w/o REMS
`REMS not required
`
`
`
`
`
`
`
`
`Comments :
`
`
`
`
`.' BLAs only: Ensure RMS—BLA Product [Iy’ormation Slieetfor TBP and RMS—BLA Facility
`Information Sheetfor TBP have been completed and forwarded to OPI/OBl/DRM (Vicky
`Yes, dates
`
`Carter)
`'
`
`
`
`
`
`
`
`'
`
`3 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA 0r BLA
`' ‘pplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA. For
`ample, if the application is a pending BLA supplement, then a new RMS—BLA Product Information Sheet/or TBP must be
`completed.
`
`Version: 6/14/13
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`NDA 204654
`
`Page 3
`
`'Q
`
`Exclusivity
`
`o
`
`Is approval of this application blocked by any type of exclusivity?
`
`Is there existing orphan drug exclusivity for the “same”
`0 NDAs and BLAs:
`drug or biologic for the proposed indication(s)? Refer to 2] CFR
`316.3(1))(1 3)for the definition of ”same drug ”for an Olphan drug (i. e.,
`active moiety). This definition is NOT the same as that usedfor NDA
`chemical classification.
`
`Is there remaining 5—year exclusivity that would bar
`(b)(2) NDAs only:
`effective approval of a 505(b)(2) application)? (Note that. even if exclusivity
`remains, the application may be tentatively approved if it is otherwise ready
`for approval.)
`
`Is there remaining 3—year exclusivity that would bar
`(b)(2) NDAs only:
`effective approval of a 505(b)(2) application? (Note that, even if’exclusivizgz
`remains, the application may be tentatively approved if it is otherwise ready
`for approval.)
`
`Is there remaining 6—month pediatric exclusivity that
`(b)(2) NDAs only:
`would bar effective approval of a 505(b)(2) application? (Note that, even if
`exclusivitv remains, the application may be tentatively approved if it is
`otherwise reatbrfbr approval.)
`
`
`
`3 Yes
`No
`If, yes, NDA/BLA #
`date exclusivity expires:
`
`and
`
`
`
`
`
`If yes, NDA #
`exclusivity expires:
`
`No
`
`
`
`:I Yes
`and date
`
`
`
`
`No
`
`If yes, NDA #
`exclusivity expires:
`
`
`
`
`If yes, NDA #
`exclusivity expires:
`
`I Yes
`
`and date
`
`No
`
`
`
`Yes
`and date
`
`Is this a single enantiomer that falls under the 10—year approval
`NDAs only:
`
`Yes
`E No
`limitation of 505(11)? (Note that, even if the 10—year approval limitatiOn
`and date 10-
`If yes, NDA #
`period has not expired, the application may be tentatively approved if it is
`year limitation expires:
`
`otherwise readyfor approval.)
`
`
`
`
`
`Verify that form FDA—3542a was submitted for patents that claim the drug for
`which approval is sought.
`If the drug is an old antibiotic, skip the Patent
`Certification questions.
`
`Patent Certification [505(b)(2) applications]:
`Verify that a certification was submitted for each patent for the listed dmg(s) in
`the Orange Book and identify the type of certification submitted for each patent.
`
`[505(b)(2) applications] If the application includes a 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
`approval).
`
`[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 infringed (review
`documentation of notification by applicant and documentation of receipt of
`notice by patent owner and NDA holder). (If the application does not include
`any paragraph 1 V certifications, mark "N/A ” and ship to the next section below
`(Summary Reviews)).
`
`
`
`O9
`
`
`
`Verified
`
`X
`
`
`
`
`Not applicable because drug is
`an old antibiotic.
`
`
`21 CFR 314.50(i)(l)(i)(A)
`
`Verified
`
`
`
`
`CFR314.50(i)(1)
`(ii)
`l:|
`(iii)
`
`
`
`
`
`
`
`No paragraph III certification
`Date patent will expire
`
`
`
`
`
`N/A (no paragraph IV certification)
`Verified
`
`’
`Patent Information (NDAs only)
`Patent Information:
`.
`
`
`
`Version: 6/14/13
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`NDA 204654
`
`Page 4
`
`
`-
`
`[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?
`
`(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))).
`
`[f ”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
`infringement after receiving the applicant’s notice of certification, as
`provided for by 21 CFR 314.107(t)(3)?
`
`if ”Yes, ” there is no stay of approval based on this certification. Analyze the next
`paragraph I V certification in the application, ifany.
`lfthere are no other
`paragraph I V certifications, skip the rest ofthe patent questions.
`
`if “N0, ” 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?
`
`(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 of the 45—day period described in question (I) 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
`infringement within the 45-day period described in question (1), as
`provided for by 21 CFR 314.107(f)(3)?
`
`If "Yes, " there is no stay of approval based on this certification Analyze the next
`paragraph I V certification in the application, ifany. If there are no other
`paragraph IV certifications, skip to the next section below (Summary Reviews).
`
`lf ”N0, ” continue with question (5).
`
`
`
`
`
`
`Yes
`
`E] No
`
`
`
`
`
`
`Yes
`
`
`
`
`
`
`No
`
`
`
`
`
`
`Yes
`
`D No
`
`
`
`
`
`
`Yes
`
`[:I No
`
`
`
`
`
`
`
`
`
`Version: 6/14/13
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`NDA 204654
`
`Page 5
`
`(5) Did the patent owner, its representative, or the exclusive patent licensee
`bring suit against the (b)(2) applicant for patent infringement 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(f)(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 of approval based on this certification. Analyze the
`next paragraph 1V certification in the application, ifany. If there are no other
`paragraph IV certifications, skip to the next section below (Summary
`Reviews).
`
`lf “Yes, ” a stay of'approval may be in efi’ect. To determine if a 30—month stay
`is in effect, consult with the 0ND ADR/l and attach a summary ofthe
`response.
`
`CONTENTS OF ACTION PACKAGE
`
`‘3‘ Copy of this Action Package Checklist“1
`
`Officer/Employee List
`
`
`
`
`
`
`Yes
`
`
`
`
`
`
`No
`
`Included
`
`
`v List of officers/employees who part1c1pated 1n the de0181on to approve this applicatlon and Y Included
`
`consented to be identified on this list (approvals only)
`
`
`Documentation of consent/non—consent by officers/employees
`
`5
`
`Included
`
`Action(s) and date(s) Approval on
`July 24’ 2013
`’1' Copies of all action letters (inch/{ling approval letter withfinal labeling
`
`
`I
`
`. Action Letters
`
`>
`
`
`
`Labeling
`
`
`
`
`
`
`
`'3' Package Insert (write submission/eomnmnication date at upper right offirst page ofPl)
`
`
`See Approval Letter for final
`0 Most recent draft labeling. If it is division—proposed labeling, it should be in
`track-changes format.
`...........................................................................................................................labeling..................................................................................................................
`
`0
`
`Example of class labeling, if applicable
`
`
`
`
`
`4 Fill in blanks with dates of reviews, letters, etc.
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`Version: 6/14/13
`
`

`

`
`
`X] Included
`
` \I/A
`
`5 RPM 11/14/2012
`X} DMEPA 05/21/2013,
`
`07/12/2013
`
`
`>< 81DAI§DDTDIDPB$IDAIEI§I07H 9/2013
`
`K SEALD 07/23/2013
`
`CSS
`
`Other reviews
`
`Included 11/14/2012
`
`X Not a (b)(2)
`X Not a (b)(2)
`
`Y Included 07/24/2013
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NDA 204654
`
`Page 6
`
`Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right offirst page of each piece)
`
`- Most—recent draft labeling. If it is division—proposed labeling, it should be in
`track—changes format.
`
`Example of class labeling, if applicable
`
`v Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right offirst page Ofeach submission)
`
`
`0 Most—recent draft labeling
`
`v Proprietary Name
`0
`Acceptability/non—acceptability letter(s) (indicate date(s))
`0
`Review(s) (indicate date(s)
`0
`Ensure that both the proprietary name(s), ifany, and the generic name(s) are
`listed in the Application Product Names section ofDARRTS, and that the
`proprieta/y/trade name is checked as the ‘preferred’ name.
`
`‘1‘ Labeling reviews (indicate dates of'reviei/vs and meetings)
`
`'2‘ Administrative Reviews (e. g, RPM Filing Revieud/Memo ofFiling Meeting) (indicate
`date of each review)
`'2' All NDA (b)(2) Actions: Date each action cleared by (b)(2) Clearance Cmte
`2? NDA (b)(2) Approvals Only: 505(b)(2) Assessment (indicate date)
`
`'1‘ NDAs only: Exclusivity Sunnnary (signed by Division Director)
`
`v Application Integrity Policy (AIP) Status and Related Documents
`http ://www. fda. Uov/ICE CI/EnforcementActions/Applic ati o nInte gritvPolicv/default. htm
`
`0
`
`This application is on the AIP
`
`o
`
`If yes, Center Director’s Exception for Review memo (indicate date)
`
`
`
`
`
`0
`
`o"
`
`
`
`
`
`
`
`
`Medication Guide
`
`Patient Package Insert
`Instructions for Use
`
`Device Labeling
`X None
`
`
`
`
`
`
` 0
`
`Administrative / Regulatory Documents
`XI
`
`If yes, OC clearance for approval (indicate date of'clearance
`o
`:| Not an AP action
`.
`.
`communication)
`Pediatrics (approvals only)
`0
`Date reviewed by PeRC
`
`If PeRC review not necessary, explain:
`
`Included
`Pediatric Page/Record (approvals only, must be reviewed by PERC be are
`
`
`
`finalized)
`
`
`
`5 Filing reviews for scientific disciplines should be filed behind the respective discipline tab.
`
`Version: 6/14/13
`
`Reference ID: 3351894
`Reference ID: 3351894
`
`

`

`NDA 204654
`
`Page 7
`
`
`
`‘3' Debarment certification (original applications only): verified that qualifying language was
`not used in certification and that certifications from foreign applicants are cosigned by
`U.S. agent (include certification)
`
`\
` /< Verified, statement is
`acceptable
`
`v Outgoing communications (letters, including response to FDRR (do not include previous
` X] Included
`action letters in this tab), emails, foxes, telecons)
`
`Internal memoranda, telecons, etc.
`'1'
`
`'2‘ Minutes of Meetings
`
`
`
`
`
`
`
`
`
`
`
`
`‘
`
`0
`
`48—hour alert or minutes, if available (do not include transcript)
`
`Decisional and Summary Memos
`
`'1‘ Office Director Decisional Memo (indicate (lotefor each review)
`
`Cross-Discipline Team Leader Review (indicate (latefor each review)
`
`PMR/PMC Development Templates (indicate total numbez)
`
`Clinical Information6
`
`0
`
`0
`
`'1' Financial Disclosure reviews(s) or location/date if addressed in another review
`OR
`
`X None
`
`
`
`x None
`
`
`
`
`X Included
`
`Clinical Reviews
`
`See CDTL Review
`.
`.
`_
`_
`.......Elncludedll/28/2012.................................................
`Clinical revrew s
`intlicat) date 0 '
`’
`)
`l
`‘
`'m
`
`W ‘f’.....5.75.1.3???______.7 .......................................................................................................................... 07/05/2013
`
`
`Y None
`Social scientist review(s) (if OTC drug) (indicate (lotefor each review)
`
`
`If no financial disclosure information was required, check here E] and include a
`
`review/memo explaining why not (indicate (late ofreview/memo)
`
`'2' Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`Y None
`
`—
`(late ofench review)
`
`.
`—
`’2' Controlled Substance Staff review(s) and Scheduling Recommendation (indicate (late of
`Not applicable
`'
`each review)
`
`v Risk Management
`
`-
`0
`0
`
`REMS Documents and Supporting Statement (indicate (late(s) ofsit/mission (s))
`REMS Memo(s) and letter(s) (indicate (late(s))
`Risk management review(s) and recommendations (including those by OSE and
`CSS) (indicate (late ofeach review and indicate location/(