CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`022272Orig1s027
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`EXCLUSIVITY SUMMARY
`
`NDA # 022272
`
`SUPPL # S-027
`
`HFD # 170
`
`Trade Name: OXYCONTIN
`
`Generic Name: oxycodone extended-release tablets
`
`Applicant Name: Purdue Pharma L.P.
`
`
`
`Approval Date, If Known: August 13, 2015
`
`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
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`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`SE5
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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.")
`
` 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:
`
`
`
`Reference ID: 3805900
`
`Page 1
`
`

`

`(1) Did the applicant request exclusivity?
`
`YES X
`
`NO D
`
`Ifflle answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`6 months of pediatric exclusivity
`
`conduct of clinical trials essential for approval of this application.
`
`00(4)
`
`based on the
`
`e) Has pediatric exclusivity been granted for this Active Moietv?
`
`om)
`
`Ifthe answer to the above guestion in YESi is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
`
`(m4)
`
`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?
`
`YESD
`
`NOQ
`
`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).
`
`PART II
`
`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`
`(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 ofthe 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.
`
`YESE
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`NOl:I
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`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
`
`Reference ID: 3805900
`
`Page 2
`
`

`

`#(s). Many NDAs and ANDAs.
`
`
`NDA#
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`NDA#
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`NDA#
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`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
`
`Reference ID: 3805900
`
`Page 3
`
`

`

`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
`
`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
`
`Reference ID: 3805900
`
`Page 4
`
`

`

`sponsored by the applicant or other publicly available data that could independently
`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:
`
`i. A Multicenter, Inpatient, Open-Label, Dose-Ranging Study to Characterize the
`Pharmacokinetics and Safety of an Oral Liquid Formulation of Oxycodone in
`Patients From Birth to 4 Years, Who Require Opioid Analgesia
`
`ii. Multicenter, Double Blind, Randomized, Dose Ranging Study, in Pediatric
`Patients 5 to ≤ 16 Years of Age Receiving Morphine As Standard Supplemental
`Pain Medication, to Evaluate Pharmacokinetics, Efficacy and Safety of Oxy
`Pediatric Liquid (1 mg/mL) Versus Placebo in the Treatment of Acute Moderate to
`Severe Pain
`
`iii. An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone
`Hydrochloride Controlled-release Tablets in Opioid Experienced Children from
`Ages 6 to 16 Years Old, Inclusive, with Moderate to Severe Malignant and/or
`Nonmalignant Pain Requiring Opioid Analgesics
`
`
`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
`
`Reference ID: 3805900
`
`Page 5
`
`

`

`Investigation #3
`
`
`
`YES
`
`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?
`
`Investigation #1
`
`Investigation #2
`
`Investigation #3
`
`
`
`YES
`
`YES
`
`YES
`
`
`
`
`
`NO
`
`NO
`
`NO
`
`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"):
`
`i. A Multicenter, Inpatient, Open-Label, Dose-Ranging Study to Characterize the
`Pharmacokinetics and Safety of an Oral Liquid Formulation of Oxycodone in
`Patients From Birth to 4 Years, Who Require Opioid Analgesia
`
`ii. Multicenter, Double Blind, Randomized, Dose Ranging Study, in Pediatric
`Patients 5 to ≤ 16 Years of Age Receiving Morphine As Standard Supplemental
`Pain Medication, to Evaluate Pharmacokinetics, Efficacy and Safety of Oxy
`Pediatric Liquid (1 mg/mL) Versus Placebo in the Treatment of Acute Moderate to
`Severe Pain
`
`iii. An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone
`Hydrochloride Controlled-release Tablets in Opioid Experienced Children from
`Ages 6 to 16 Years Old, Inclusive, with Moderate to Severe Malignant and/or
`Nonmalignant Pain Requiring Opioid Analgesics
`
`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
`
`Reference ID: 3805900
`
`Page 6
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`

`

`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:
`
`
`
`!!
`
`Investigation #1
`
`IND # 29038
`
`
`
`Investigation #2
`
`IND # 29038
`
`
`
`Investigation #3
`
`IND # 29038
`
`YES
`
`YES
`
`
`
`YES
`
`! NO
`! Explain:
`
`
`
`
`
`(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
`
`(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:
`
`Reference ID: 3805900
`
`Page 7
`
`

`

`=================================================================
`
`Name of person completing form: Diana L. Walker, PhD
`Title: Senior Regulatory Health Project Manager, DAAAP
`Date: August 12, 2015
`
`Name of Division Director signing form: Sharon Hertz, MD
`Title: Director, DAAAP
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
`
`Reference ID: 3805900
`
`Page 8
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`DIANA L WALKER
`08/13/2015
`
`SHARON H HERTZ
`08/13/2015
`
`Reference ID: 3805900
`
`

`

`1.3.3 DEBARMENT CERTIFICATION
`
`Purdue Pharma L.P. hereby certifies that it did not and will not use in any capacity the
`services of any person debarred under section 306 of the Federal Food, Drug, and
`Cosmetic Act in connection with this application.
`
`[if/6L)
`
`
`ichard J. Fanelli, Ph.D.
`ead of Regulatory Affairs
`
`621/ng9%
`
`Dale
`
`
`
`Reference ID: 3810536
`
`

`

`
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`ACTION PACKAGE CHECKLIST
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`BLA Supplement it
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`(an action package is not requiredfor SE8 or SE9 supplements)
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`Efficacy Supplement:
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`0
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`BLA Application Type: 1:] 351(k)
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`Efficacy Supplement:
`[:1 351(k)
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`[:1 351(a)
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`[:3 351(3)
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`Proprietary Name: OxyContin
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`Applicant: Purdue Pharrna
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`Established/Proper Name: oxycodone hydrochloride
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`Agent for Applicant (if applicable):
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`extended-release tablets
`Dosage Form:
`RPM: Diana Walker
`Division: DAAAP
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` NDA Application Type: C] 505(b)(l)
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`For ALL 505111112] applications, two months prior to EVERY action:
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`[j 505(b)(2)
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`E] 505(b)(1)
`[j] 505(b)(2)
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`Review the information in the 505(1))(2) Assessment and submit
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`the draftz to CDER 0ND 10 for clearance.
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`0 Check Orange Book for newly listed patents and/or
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`exclusivity (including pediatric exclusivity)
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`D No changes
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`[I New patent/exclusivity (notifir CDER 0ND 10}
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`Date of check:
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`Note: Ifpediatric exclusivity has been granted or the pediatric
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`information in the labeling of the listed drug changed, determine whether
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`pediatric information needs to be added to or deletedfrom the labeling of
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`this drug.
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`Proposed action
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`User Fee Goal Date is June 10, 2015. Action taken August 13, 2015
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`Actions
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`Previous actions (specs)? type and datefor each action taken)
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`If accelerated approval or approval based on efficacy studies in animals, were promotional
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`materials received?
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`Note: Promotional materials to be used within 120 days after approval must have been
`submitted (for exceptions, see
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`http :f/www. fda. gov/downloads/Drugs/GuidanceComplianceRegulatcrylnformation/Guida
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`nces/ucrn069965pdf). If not submitted, ex lain
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`‘3 Application Characteristics 3
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`I:I Received
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`l The Application Information Section is (only) a checklist. The Contents of Action Package Section (beginning on page 2) lists
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`the documents to be included in the Action Package.
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`or resubmissions, 505(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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`.essment to CDER 0ND IO unless the Assessment has been substantively revised (e.g., new listed drug, patent certification
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`revised).
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`3 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NBA or BLA
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`supplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA.Version: 7/2! 15
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`Reference ID: 3810536
`Reference ID: 3810536
`
`

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`NDA/BLA #
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`Page 2
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`.__..._..
`[... ...._..... . ..... .. . .... -_ ......... ..
`Priority
`Review priority:
`I] Standard
`Chemical classification (new NDAs only):
`(confirm chemical classification at time ofapproval)
`
`...
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`_
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`.
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`...................................................................................................................................................
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`D Fast Track
`[1 Rolling Review
`[I Orphan drug designation
`[:I Breakthrough Therapy designation
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`I: Rx-to-OTC full switch
`E] Rx-to-OTC partial switch
`C] Direct-to-OTC
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`NDAs: SubpartH
`D Accelerated approval (21 CFR 314.510)
`[:1 Restricted distribution (21 CFR 314.520)
`Subpart I
`C] Approval based on animal studies
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`BLAs: Subpait E
`E] Accelerated approval (21 CFR 601.41)
`[3 Restricted distribution (21 CFR 601.42)
`Subpart H
`Cl Approval baSed on animal studies
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`
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`D Submitted in response to a PMR
`I] Submitted in response to a PMC
`E Submitted in response to a Pediatric Written Request
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`Comments:
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`REMS: g MedGuide
`I:I Communication Plan
`ETASU
`[:1 MedGuide w/o REMS
`D REMS not required
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` BLAs only: Is the product subject to official FDA lot release per 21 CFR 6102
`(approvals only)
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`v Public communications (approvals oniy)
`0 Office ofExecutive Programs (OE?)liaisonhas been notified of action
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`0
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`Indicate what types (if any) of information were issued
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` FDA Talk Paper
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`CDER Q&As
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`E Other
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`CDER Conversation iece
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`'2' Exclusivity
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`'
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`Is approval of this application blocked by any type of exclusivity (orphan, 5-year
`NCE, 3--year, pediatric exclusivity)?
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`°t° Patent Information (NDAs only)
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`Patent Information:
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` E Verified
`Verify that form FDA-3542a was submitted for patents that claim the drug for
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`|:] Not applicable because drug is
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`which approval is sought.
`an old antibiotic.
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` 0
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`O
`{a List of officers/employees who participated in the decision to approve this application and
`consented to be. identified on this list (approvals crib)
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`Included
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`12 Included
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`Documentation of consent/non-consent by officers/employees
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`Reference ID: 3810536
`
`o
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`

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`NDA/BLA #
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`Page 3
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`.._ AcfiongLettersj.
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`.— Copies of all action letters (including approval letter with final labeling)
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`Package Insert (write submission/communication date at upper right offirst page ofPI)
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`submission/communicaiion date at upper right offirst page ofeach piece)
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`Action and date:
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`Approval: August 13, 2015
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`21 EWWWWWW Approved August 13’
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`December 2014
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`0 Most—recent draft labeling (tflt is division—proposed labeling, it Should be in
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`track-changesformat)
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`Labels (full color carton and immediate—container labels) (write
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`0 Most—recent draft labeling
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`4' Proprietary Name
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`0 Acceptabilitylnon-acceptability letter(s) (indicate date(s))
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`Review(s) (indicate date(s)
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`fl
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`El Medication Guide
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`I: Patient Package Insert
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`I:I Instructions for Use
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`|:| Device Labeling
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`I:I None
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`E Included: Approved August
`13, 2015
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`EIncludedOngmalpmposed W W
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`December 2014
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` 0 Most recent drafi labeling (ifit is division—proposed labeling, it should be in
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`'3 Labeling reviews (indicate dates ofreviews)
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`0:- All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
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`'1' NDAs only: Exclusivity Summary (signed by Division Director)
`0
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`* ' Application Integrity Policy (AIP) Status and Related Documents
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`http :l/www. fda. go vllCECI/EnforcementActions/ApplicationIntegrityP olicy/defanlthtm
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`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
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`Reference ID: 3810536
`Reference ID: 3810536
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`I February 4, 2015
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`None
`RPM:
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`DMEPA: E None
`DMPP/PLT:
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`E] None May 27, 2015
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`OPDP: E] None May 21,2015
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`SEALD: E] None
`None
`CSS:
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`None
`Product Quality
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`Other: [:I None PMHS labeling
`review dated June 1 1, 2015
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`NDA/BLA #
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`0 Applicantis on the Ale
`77
`i
`I
`V
`i
`V
`V
`77
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`This applicauon[S on theALP
`0
`If yes, Center Director’s Exception for Review memo (indicate date)
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`O 5
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`'5‘
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`I: Yes i
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`Ci Not an AP action
`If yes, 0C clearance for approval (indicate date ofclearance
`0
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` communication)
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`' Pediatrics (approvals only)
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`0
`Date reviewed by PeRC May 13, 2015
`lfPeRC review not necessary, explain:
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` '2' Breakthrough Therapy Designation
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` Breakthrough Therapy Designation Letter(s) (granted, denied, anlor rescinded)
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`CDER Medical Policy Council Breakthrough Therapy Designation
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`Determination Review Template('s) (include only the completed template{s) and
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`no! the meetin;
`'
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`0
`CDER Medical Policy Council Brief — Evaluating a Breakthrough Therapy
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`Designation for Rescission Template(s) (include only the completed template(s)
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`and not the meeting minutes)
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` (completed CDER MPC templates can befound in DARRTS as clinical reviews or on
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`the 1MPC SharePoint Site
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`'3 Outgoing communications: letters, emails, and faxes considered important to include in
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`the action package by the reviewing office/division (e.g., clinical SPA letters, RTF letter.
`Included
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`Formal Dispute Resolution Request decisional letters, etc.) (do not include previous
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`
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`action letters, as these are located elsewhere in package!
`(m4)
`Internal documents: memoranda, telecons, emails, and other documents considered
`important to include in the action package by the reviewing office/division (e.g.,
`Regulatory Briefing minutes, Medical Policy Council meeting minutes)
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`
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`.0
`.v Minutes of Meetings
`i- E N/A or no mtg
`o
`'Ifnotthe first.”review cycle, any end-of-rewew meeting (indicate date ofmtg)
`Pre-NDA/BLA“16231318..(liztiéetsfiéaemei.._tNomtg
`EOPZ We: (indicate datéofm‘g) __
`.____Ei9_9£:é._______________________________ ___________
`'
`— W0 "inlaid-cycleCommunication—lindicaledate ofmtg)
`5! N/A
`Late-cycle Meeting (indicate date ofmtg)
`N/A
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`'3 Office Director Decisional Memo (indicate datefor each review)
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`Division Directorsummary Review(indicate datefor each review)
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`Cross-Dismpline Team Leader Review (indicate datefor each review)
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`E None
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`I] None August 13,2015
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`I: None May 26,2015
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`[jNone 2 templates both dated
`PMR/PMC Development Templates (indicate total number)
`Auust 13 2015
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`
`Reference ID: 3810536
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`
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`- Date(s) of Meetmg(s)
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`0 v
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`,.........1....._.n.n..._......._”.......flwnmmm.““-....-mmw.---............1..we-n._.._...t._...__.~..-1”.............1....-........, . .....u- .... -.....“—.............................................r"-.....-.....
`....n... .. .. ,...1.-....... ..
`Advisory Committee Meeting(_s)
`I NoAC meeting
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`. .
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`...t.
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`“....
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`

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`Clinical Team Leader Rev1ew(s) (indicate datefor each rev1ew)
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`Climcal rev1ew(s) (indicate datefcr each revrew)
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`Financial Disclosure reviews(s) or location/date if addressedin another review
`OK
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`If no financial disclosure information was required, check here l3 and include a
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`Controlled Substance Staff review(s) and Scheduling Recommendation h‘ndicate date of
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`each review)
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`Risk Management
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`REMS Documents and REMS Supporting Document (indicate date(3) of
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`submissi0n(s))
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`REMS Mern0(s) and letter(s) (indicate date(s))
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`Risk management review(s) and recommendations (including those by OSE and
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`into another review)
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`081 Clinical Inspection Review Summaryfies) (include copies ofOSI letters to
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`investigators)
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`0.0
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`None
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`Included in Clinical Review dated
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`May 18, 2015.
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`g N/A
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`July 31, 3015 (see approval letter —
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`attached)
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`N/A
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`{j None August 13,2015
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`Cl None requested
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`April 30 and June 1 and 4, and
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`[I No separate review
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`C] None
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`"No separate review
`I No separate rev1ew
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`D None
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`Februar 2 and May 7, 2015
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`I No separate review
`I No separate rev1ew
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`February 4 and May 15, 2015
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`None requested
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`I No separate review February 2 and Mayl8 2015
`None
`August 71 2015 __
`.1 1:] None
`
`NDA/BLA #
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`Page 5
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`Clinical Rev1ews
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`ClinicalMerobiology
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`Clinical Microbiology Team Leader Review(s) (indicate datefor each review)
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`INone: I
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`' .' .Bissmiisties; *
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`Stat1st1cal DIVISIOII Dlrector Rev1ew(s) (indicate datefor each rev1ew)
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`Statist1cal Team Leader Rev1ew(s) (indicate date for each rev1ew)
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`Statistical Review(s) (indicate datefor each review)
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`“Chmcal Pharmacology
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`Chmcal Pharmacology D1v1s1on Director Rev1ew(s) (indicate datefor each revtew)
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`Clinical Pharmacology Team Leader Rev1ew(s) (indicate datefor each review)
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`None
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`Clinical Pharmacology review(s) (indicate datefor each review)
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`0:0 OSI Clinical Pharmacology Inspection Review Summary (include copies of051' letters)
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`Reference ID: 3810536
`Reference ID: 3810536
`
`

`

`NDA/BLA #
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`Page 6
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`' :Nonclinical-‘ “ -‘
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`I:] No separate review
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`|:] No separate review
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`E] None
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`Pharmacology/Toxrcoiogy D1sc1pl1ne Rev1ews
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`- ADPIT Rev1ew(s) (1nd1cate date f01 each 1ev1ew)
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`0
`Superwsory Rev1ew(s) (indicate datefor each 1ev1ew)
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`a - Pharm/tox rev1ew(s) 1nclud1ng referenced IND reviews (1nd1cate datefor each
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`review)
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`'3' Review(s) by other disciplinesidivisions/Centers requested by P/T reviewer (indicate date
`[3 None
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`for each review)
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`'2' Statistical review(s) of carcinogenicity studies (indicate datefor each review)
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`a.
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`[3 None
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`ECAC/CAC report/memo of meetmg
`Included in P1’1" review page
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`CI Nonerequested
`-OSiNonclinicalInspectionReview Summary (include copiesIofOSIletters).
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`Product Quality
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`Product Quahty Discrplme Rev1ews
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`E None
`Tertiary review (indicate datefor each rev1ew)
`E None
`Secondary review (eg., Branch Chief) (indicatedatefor each review)
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`“Tm"IntegratedQuality Assessment (contams the Executive Summary andtiiemprimary
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`reviews from each product quality review discipline) (indicate date for each
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`review)
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`‘2' Reviews by other disciplines/divisions/Centers requested by product quality review team
`(indicate date ofeach review)
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`[:1 None May 11, 2015
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`V
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`None
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`v Env1ronmental Assessment (check one) (original and supplemental appl1cat1ons)
`g Categorical Exclusron (indicate review date)(ail original applications and
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`Mali. efl'cacy supplements that couldincreasethepatientpopulation)
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`D Review & FONSI (indicate dateof.revzew)
`[:l Review & Env1ronmental Irnpact Statement (indicate date ofeach review)
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`me ES’ 2015
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`Facilities Review/Inspection
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`Cl Facilities inspections (action must be taken prior to the re-evaiuation date) (only
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`original applications and eflicacy supplements that require a manufacturing
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`facility inspection(e.g., new strength, manufacturing process, or manufacturing
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`site change)
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`:3 Acceptable
`Re—evaiuation date:
`
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`
`El Withhold recommendation
`
`.1 ENotapphcable____
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`9 v
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`
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`Reference ID: 3810536
`Reference ID: 3810536
`
`

`

`NDA/BLA #
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`Page 7
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`DayoprprovalActwlties:
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`'
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`'_
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`' "
`'
`'
`"wattage; "'
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`E] New patent/exclusivity (Nottfi
`For all 505(b)(2) applications.
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`CDER 0ND 10)
`Check Orange Book for newly listed patents and/0r excius1v1ty (including
`I
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`
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`pediatric exclusivity)
`
`E] Done
`
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`I:] Done
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`(Send email to CDER 0ND 10)
`
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`0
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`.i
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`' .
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`Done
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`Done
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`Finalize 505(b)(2) assessment
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`"' For Breakthrough Therapy (BT) Designated drugs:
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`Notify the CDER BT Pro ram Mana
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`"‘ For products that need to be added to the flush list (generally opioids): Flush List
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`I Notify the Division of Online Communications, Office of Communications
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`Send a courtesy copy of approval letter and all attachments to applicant by fax or secure
`email
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