CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`206321Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`EXCLUSIVITY SUMMARY
`
`NDA # 206321
`
`SUPPL #
`
`HFD # 510
`
`Trade Name Saxenda
`
`Generic Name liraglutide injection, 3 mg
`
`Applicant Name Novo Nordisk
`
`
`
`Approval Date, If Known 12/23/14
`
`PART I
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`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.
`
`N/A
`
`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:
`
`N/A
`
`
`
`Reference ID: 3677955
`
`Page 1
`
`

`

`d) Did the applicant request exclusivity?
`
`YES
`
`NO
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`Did not request specific # of years
`
`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?
`
`
`
`N/A
`
`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 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.
`
`
`
`
`
`YES
`
`NO
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`Reference ID: 3677955
`
`Page 2
`
`

`

`022341
`
`Victoza
`
`
`NDA#
`
`NDA#
`
`NDA#
`
`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#
`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
`
`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
`
`Reference ID: 3677955
`
`Page 3
`
`

`

`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
`
`NO
`
`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?
`
`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
`
`Reference ID: 3677955
`
`Page 4
`
`

`

`demonstrate the safety and effectiveness of this drug product?
`
`YES
`
`NO
`
` If yes, explain:
`
`
`
`(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:
`
`1.
`2.
`
`Trial 1839: Obese and overweight subjects with comorbidities
`Trial 1922; Obese and overweight subjects with T2DM
`
`
`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
`
`
`
`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:
`
`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?
`
`Reference ID: 3677955
`
`Page 5
`
`

`

`Investigation #1
`
`Investigation #2
`
`YES
`
`YES
`
`NO
`
`NO
`
`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`N/A
`
`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"):
`
`1.
`2.
`
`Trial 1839: Obese and overweight subjects with comorbidities
`Trial 1922; Obese and overweight subjects with T2DM
`
`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?
`
`
`
`!!
`
`! NO
`! Explain:
`
`
`
`!!
`
`
`! NO
`! Explain:
`
`Page 6
`
`Investigation #1
`
`IND # 73206
`
`YES
`
`
`
`Investigation #2
`
`IND # 73206
`
`YES
`
`
`
`
`
`Reference ID: 3677955
`
`

`

`
`(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? N/A
`
`!!
`
`
`! NO
`! Explain:
`
`!!
`
`
`! NO
`! Explain:
`
`Investigation #1
`
`YES
`Explain:
`
`
`
`Investigation #2
`
`YES
`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: Patricia Madara
`Title: Regulatory Project Manager
`Date: 12/23/14
`
`Name of Office/Division Director signing form: James P. Smith
`Title: Deputy Director (acting), DMEP
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
`
`Reference ID: 3677955
`
`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/
`----------------------------------------------------
`
`PATRICIA J MADARA
`12/23/2014
`
`JAMES P SMITH
`12/23/2014
`
`Reference ID: 3677955
`
`

`

`
`
`
`ACTION PACKAGE CHECKLIST
`
`
`
`
` APPLICATION INFORMATION1 -
`
`"—l
`
`
`
`
`
`NDA Supplement #
`NDA # 206321
`
`
`
`
`BLA Supplement #
`BLA #
`
`
`
`
`
`If NDA, Efficacy Supplement Type:
`
`
`
`
`
`
`
`
`
`
`(an action package is not requiredfor SE8 or SE9 supplements)
`
`
`
`
`
`
`Proprietary Name: Saxenda
`
`
`
`
`liraglutide [rDNA origin]
`Established/Proper Name:
`
`
`
`injection
`Dosage Form:
`
`RPM: Patricia Madara
`
`
`
`
`
`
`
`
`
`
`NDA Application Type:
`
`
`Efficacy Supplement:
`
`
`
`
`{XI 505(b)(1) E] 505(b)(2)
`
`
`
`El 505(b)(1) El 505(b)(2)
`
`
`
`
`
`
`
`BLA Application Type: C] 351(k)
`I:I 351(a)
`
`
`
`
`
`
`Efficacy Supplement:
`[:1 351(k)
`I] 351(a)
`
`
`
`
`Applicant: Novo Nordisk
`
`
`
`
`Agent for Applicant (if applicable):
`
`
`
`
`
`
`Division: DMEP
`
`
`
`
`
`
`
`
`
`
`For ALL 505(b)(2) applications, two months prior to EVERY action:
`
`
`
`
`0
`
`.
`
`
`
`
`Review the information in the 505(b)(2) Assessment and submit
`
`
`
`
`
`
`
`
`
`the draft2 to CDER 0ND 10 for clearance.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Check Orange Book for newly listed patents and/or
`
`
`
`
`exclusivity (including pediatric exclusivity)
`
`
`
`
`
`
`
`
`E] No changes
`
`
`
`
`
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`[I New patent/exclusivity (notify CDER 0ND 10)
`Date of check:
`
`
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`Note: Ifpediatric exclusivity has been granted or the pediatric
`
`
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`
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`information in the labeling ofthe listed drug changed, determine whether
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`pediatric information needs to be added to or deletedfrom the labeling of
`
`
`this drug.
`
`
`
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`0
`Proposed action
`
`
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`0 User Fee Goal Date is 10/20/14
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`Previous actions (specify type and date for each action taken)
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`If accelerated approval or approval based on efficacy studies in animals, were promotional
`materials received?
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`
`
`Note: Promotional materials to be used within 120 days after approval must have been
`
`
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`
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`submitted (for exceptions, see
`
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatorylnformation/Guida
`
`
`
`
`
`
`nces/ucm069965pdi). If not submitted, explain
`,
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`
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`
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`[:1 Received
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`
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`1 The Application Information Section is (only) a checklist. The Contents of Action Package Section (beginning on page 2) lists
`
`
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`
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`the documents to be included in the Action Package.
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`2 For resubmissions, (b)(2) applications must be cleared before the action, but it is not necessary to resubmit the draft 505(b)(2)
`
`
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`
`
`
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`
`
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`Assessment to CDER 0ND 10 unless the Assessment has been substantively revised (e. g., new listed drug, patent certification
`
`revised).
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`. Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA
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`applement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA. For
`
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`example, if the application is a pending BLA supplement, then a new RMS—BLA Product Information Sheetfor TBP must be
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`completed.
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`Version: 2/7/2014
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`0
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`0 v
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`

`

`NDA 206321
`
`
`Page 2
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`[:1 Priority
`XI Standard
`Review priority:
`
`
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`
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`Chemical classification (new NDAs only):
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`
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`
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`(confirm chemical classification at time of approval)
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`
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`I: Fast Track
`
`
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`I:] Rolling Review
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`
`
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`1:] Orphan drug designation
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`[:1 Breakthrough Therapy designation
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`
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`CHINE
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`
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`Rx-to-OTC full switch
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`
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`
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`Rx-to-OTC partial switch
`Direct-to-OTC
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`NDAs: Subpart H
`
`
`
`
`
`
`
`1:] Accelerated approval (21 CFR 314.510)
`
`
`
`
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`E] Restricted distribution (21 CFR 314.520)
`
`Subpart I
`
`
`
`
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`E] Approval based on animal studies
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`E] Submitted in response to a PMR
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`I:] Submitted in response to a PMC
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`[:1 Submitted in response to a Pediatric Written Request
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`Cements:
`
`
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`BLAs: Subpart E
`
`
`
`
`
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`I:I Accelerated approval (21 CFR 601.41)
`
`
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`
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`E] Restricted distribution (21 CFR 601.42)
`
`Subpart H
`i
`
`
`
`
`
`[:1 Approval based on animal studies
`
`
`
`
`
`REMS:
`
`
`
`
`
`[:1 MedGuide
`
`
`K4 Communication Plan
`
`
`ETASU
`BENZ]
`
`MedGuide w/o REMS
`
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`REMS not required
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`‘3' BLAS only: Ensure RMS—BLA Product Information Sheetfor TBP and RMS—BLA Facility
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`Information Sheetfor TBP have been completed and forwarded to OPI/OBI/DRM (Vicky
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`Carter)
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`at. BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`
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`(approvals only)
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`[:1 Yes, dates
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`[:1 Yes E] No
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`Indicate what types (if any) of information were issued
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`IX]
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`E] FDA Talk Paper
`
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`E]
`CDER Q&As
`Other
`
`
`El
`
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`
`
`
`
`-
`
`If so, specify the type
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`I:] Yes
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`'3' Exclusivity
`
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`Is approval of this application blocked by any type of exclusivity (orphan, 5-year
`
`
`
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`NCE, 3-year, pediatric exclusivity)?
`
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`0
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`4' Patent Information (NDAs only)
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`0
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`Patent Information:
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`Verify that form FDA-3542a was submitted for patents that claim the drug for
`
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`which approval is sought.
`
`
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`IE Verified
`
`
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`
`E] Not applicable because drug is
`an old antibiotic.
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`CONTENTS OF ACTION PACKAGE
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`Officer/Employee List
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`Labeling
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`4 Filing reviews for scientific disciplines should be filed with the respective discipline.
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`NDA 206321
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`Date reviewed by PeRC 10/8/14
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`v Internal documents: memoranda, telecons, emails, and other documents considered
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`""""""""""""""""""""""""IfnotthefirstreVIewcycleanyendofrev1ewmeet1ng(mdzcatedateofmtg)[ g N/A or no mtg
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`................Eopzmeetmg(mdlcatedateofmtg)............................................................................................................................................................................................... DNomtg3/10/2008
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`U Date(s) of Meeting(s)
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`'3 Financial Disclosure reviews(s) or location/date if addressed in another review
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`6° Clinical reviews'from immunology and other clinical areas/divisions/Centers (indicate
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`[:1 None 11/10/14 (acting deputy
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`I:] None
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`E] None 9 templates 12/23/14
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`same as above
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`X No separate review see acting
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`NDA 206321
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`4‘ Controlled Substance Staff review(s) and Scheduling Recommendation (indicate date of
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`'2' N/A
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`Final submission — 12/ 1 7/ 14 — see
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`I] None requested Summary
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`IE No separate review
`'9 Clinical Pharmacology Division Director Review(s) (indicate datefor each review)
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`....................(311111031phamacologyTeamLeaderReweMs)(mdlcatedateforezwhrewew) ®.Noseparaterewew
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`.................C—llvmcalPharmacoiogyrewew(s)(Indlcatedateforeachrewew)'_ DNoneg/19/14and2/26/14
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`WEI
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`Version: 2/7/2014
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`NDA 206321
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`D None
`Product Quality
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`[Z No separate review
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`I:] None 10/21/14 (memo)
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`5/14/14 and 1/23/ 14
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`'3' Microbiology Reviews
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`E Categorical Exclusion (indicate review date)(all original applications and
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` I] Review & Environmental Impact Statement (indicate date ofeach review)
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`RCVICW 5/14/14' pages 28—29
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`'1' Facilities Review/Inspection
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`""""""""""""""""""""""""DNDASFac1l1tiesmspect10ns(includeEERprmtoutorEERSummaryReport
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`only; do NOT include EER Detailed Report; date completed must be within 2
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`years of action date) (only original NDAs and supplements that include a new
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`facility or a change that afi’ects the manufacturing sztes )
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`D BLAs: TB-EER (date of most recent TB-EER must be within 30 days of action
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`date) (original and supplemental BLAs)
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`rt. NDAs: Methods Validation (check box only, do not include documents)
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`Date completed: 10/20/14
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`Acceptable
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`E] Withhold recommendation
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`CI Not apphcable
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`Date completed:
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`[:1 Acceptable
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`D Withhold recommendation
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`D Completed
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`[:1 Requested
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`IX] Not yet requested
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`El Not needed (per review)
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`5 i.e., a new facility or a change in the facility, or a change in the manufacturing process in a way that impacts the Quality
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`Management Systems of the facility.
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`Version: 2/7/2014
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`NDA 206321
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`Page 7
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`Day of Approval Activities
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`[:1 No changes
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`'3 For all 505(b)(2) applications:
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`D New patent/exclusivity (Notzfi/
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`0 Check Orange Book for newly listed patents and/or exclusivity (including
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`CDER 0ND 10)
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`pediatric exclusivity)
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`I] Done
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`Done
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`[:I Done
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`IX Done
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`Version: 2/7/2014
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`0
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`Finalize 505(b)(2) assessment
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`'3'
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`O 0
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`4' Send a courtesy copy of approval letter and all attachments to applicant by fax or secure
`email
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`If an FDA communication will issue, notify Press Office of approval action after
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`confirming that applicant received courtesy copy of approval letter
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`v Ensure that proprietary name, if any, and established name are listed in the
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`Application Product Names section of DARRTS, and that the proprietary name is
`identified as the “oreferred” name
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` E]
`Done
`.. Ensure Pediatric Record is accurate
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`0? Send approval email within one business day to CDER-APPROVALS
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`From: Guettier, Jean‐Marc  
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`Sent: Monday, December 22,