CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
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`APPLICATION NUMBER:
`202788Orig1s000
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`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
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` YES
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`NO
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`NDA # 202788
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`EXCLUSIVITY SUMMARY
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`SUPPL #
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`HFD # 170
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`Trade Name Subsys
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`Generic Name fentanyl sublingual spray
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`Applicant Name Insys Therapeutics
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`Approval Date, If Known Jan 4, 2012
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`PART I
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`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
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`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
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`505(b)(2)
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`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
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` YES
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`NO
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`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
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`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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`Reference ID: 3065916
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`Page 1
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`

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`d) Did the applicant request exclusivity?
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` YES
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`NO
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`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
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`e) Has pediatric exclusivity been granted for this Active Moiety?
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` YES
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`NO
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`If the answer to the above question in YES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
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`No
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
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`2. Is this drug product or indication a DESI upgrade?
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` YES
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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` YES
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`NO
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`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
`
`
`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: 3065916
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`Page 2
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`NDA#
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`NDA#
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`019813
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`020747
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`NDA#
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`022266
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`NDA#
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`022510
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`NDA#
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`021947
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`NDA#
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`016619
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`NDA#
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`021338
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`NDA #
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`022569
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`Duragesic
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`Actiq
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`Onsolis
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`Abstral
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`Fentora
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`Sublimaze
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`Ionsys
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`Lazanda
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`fentanyl
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`refer to Orange book
`various
`for complete list
`ANDAs
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`2. Combination product.
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`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing any one of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
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`YES
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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`NDA#
`NDA#
`NDA#
`
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`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
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`Reference ID: 3065916
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`Page 3
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
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`PART III
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`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.
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`YES X
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`NO
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`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
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`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
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`(a) In light of previously approved applications, is a clinical investigation (either conducted
`by the applicant or available from some other source, including the published literature)
`necessary to support approval of the application or supplement?
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` YES X
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`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`NO
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`(b) Did the applicant submit a list of published studies relevant to the safety and
`effectiveness of this drug product and a statement that the publicly available data would not
`independently support approval of the application?
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`NO X
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` YES
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`Reference ID: 3065916
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`Page 4
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`

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`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
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` YES
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`NO
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` If yes, explain:
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`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
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` YES
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`NO X
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` If yes, explain:
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`(c)
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`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical
`investigations submitted in the application that are essential to the approval:
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`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
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`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
`
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
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`Reference ID: 3065916
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`Page 5
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`

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`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO X
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`NO
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`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
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`
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`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO X
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`NO
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`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
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`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
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`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
`
`Study INS-05-001, A Randomized, Double-Blind, Placebo-Controlled, Multi-Center
`Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL
`Spray) for the Treatment of Breakthrough Cancer Pain
`
`
`
`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?
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`Reference ID: 3065916
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`Page 6
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`Investigation #1
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`IND # 72,411
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`YES X
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`Investigation #2
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`!
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`! NO
`! Explain:
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`!
`!
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`! NO
`! Explain:
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`YES
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`IND #
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`(b) For each investigation not carried out under an IND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
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`
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`Investigation #1
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`YES
`Explain:
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`Investigation #2
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`YES
`Explain:
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`!
`!
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`! NO
`! Explain:
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`!
`!
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`! NO
`! Explain:
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`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
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`YES
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`NO X
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`If yes, explain:
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`Reference ID: 3065916
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`Page 7
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`

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`
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`=================================================================
`
`Name of person completing form: Sharon Hertz, M.D.
`Title: Deputy Director
`
`Date: 12/28/11
`
`
`Name of Office/Division Director signing form: Bob A. Rappaport, MD
`Title: Director
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`
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`RPM: S. Stradley 12/28/11
`
`
`
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`Reference ID: 3065916
`
`Page 8
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SARA E STRADLEY
`01/03/2012
`
`BOB A RAPPAPORT
`01/04/2012
`
`Reference ID: 3065916
`
`

`

`il'lS‘r’S
`
`’I‘HERAF’EUTiGS, {Nil
`
`
`Debarment Certification
`
`CERTIFICATION PURSUANT TO SECTION 306(K)(l) OF THE GENERIC DRUG
`
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`ENFORCEMENT ACT OF 1992 [21 USC § 335A(K)(l)]
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`This is to certify:
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`(1) that Insys Therapeutics, Inc. did not use in any capacity the services of any person
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`debarred under subsection (a) or
`(b) of this section in connection with the
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`development or submission of this application;
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`(2) that Insys Therapeutics, Inc. will not use in any capacity the services of any person
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`debarred under subsection (a) or (b) if this section in connection with this application;
`and
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`Inc. nor affiliated persons responsible for the
`(3) that neither Insys Therapeutics,
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`development or submission of this application have been convicted within the past
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`five (5) years of offenses described in subsections (a) and (b) of this section.
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`List of convictions: None
`
`Mi
`
`
`
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`
`
`ael L. \Babich
`
`
`
`
`President & Chief Operating Officer
`
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`INSYS THERAPEUTICS, INC.
`
`
`
`
`
`Date
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`10220 South Slsi‘SEwet Suite?
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`E Phoenix, AZ 85044
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`
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`phrase: 027 ”1%?
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`ééil?,9l3.2c’3??
`
`!
`
`fit’t‘i‘fiiféfifxfcm
`
`Reference ID: 3069057
`Reference ID: 3069057
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`Importance:
`
`Davies, Kathleen
`Stradley, Sara; Hertz, Sharon H; Yip, Luke; Qiu, Wei; Xu, Yun (CDER)
`FW: NDA 202-788 Fentanyl SL Spray
`Friday, December 09, 2011 9:35:49 AM
`1 Pediatric Record.pdf
`High
`
`______________________________________________
`From: Greeley, George
`Sent: Friday, December 09, 2011 9:35 AM
`To: Davies, Kathleen
`Cc: Mathis, Lisa; Addy, Rosemary; Suggs, Courtney; Lee, Catherine S.; Rappaport, Bob A
`Subject: NDA 202-788 Fentanyl SL Spray
`Importance: High
`
`Hi Kathleen,
`
`The email serves as confirmation of the review for the Fentanyl Sublingual
`Spray product conducted by the PeRC PREA Subcommittee on December 7,
`2011.
`
`The Division presented a full waiver in patients for the indication of
`management of breakthrough cancer pain in patients with malignancies
`who are already receiving and who are tolerant to opioid therapy for their
`underlying cancer because there are too few children with disease/condition
`to study.
`
`The PeRC agreed with the Division to grant a full waiver for this product.
`
`The pediatric record is attached for Fentanyl.
`
`Thank you.
`
`George Greeley
`Regulatory Health Project Manager
`Pediatric and Maternal Health Staff
`FDA/CDER/OND
`10903 New Hampshire Avenue
`Bldg. 22, Room 6467
`Silver Spring, MD 20993-0002
`Phone: 301.796.4025
`Email: george.greeley@fda.hhs.gov
`ü Please consider the environment before printing this e-mail.
`
`Reference ID: 3060231
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SARA E STRADLEY
`12/17/2011
`
`Reference ID: 3060231
`
`

`

`ACTION PACKAGE CHECKLIST
`
`NDA # 202788
`BLA #
`
`NDA Supplement #
`BLA STN #
`
`.
`IfNDA Efficacy Supplement Type.
`
`Proprietary Name: Subsys
`.
`.
`Estabhshed/Proper Name: fentanyl subhngual spray
`Dosage Form:
`sublin
`l spray
`
`RPM: Katmeennm-esanasmsmaey
`
`Applicant: Insys Therapeutics
`_
`.
`.
`.
`Agent for Apphcant (1f apphcable).
`
`NDAs:
`
`505
`
`2 Ori
`
`'
`
`NDAs and 505
`
`2 NDA su
`
`laments:
`
`NDA Application Type: D 505(b)(1) E 505(b)(2) Listed drug(s) relied upon for approval (include NDA #(s) and drug
`Efficacy Supplement: D 505(b)(1) D 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)
`
`Actiq (NDA 20747)
`Provide a brief explanation of how this product is different from the listed
`drug.
`
`fizfigt or the Appendix to this Action Package
`
`new dosage form
`
`If no listed drug, explain.
`D This application relies on literature.
`I] This application relies on a final OTC monograph.
`El Other (explain)
`
`Two months prior to each actionI review the information in the
`505
`2 Assessment and submit the draft to CDER 0ND IO 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.
`
`X No changes
`
`I] Updated Date of check:
`
`If pediatric exclusivity has been granted or the pediatric information in
`the labeling of the listed drug changed, determine whether pediatric
`information needs to be added to or deleted from the labeling of this
`drug.
`
`E] Received
`
`Actions
`
`Proposed action
`0
`0 User Fee Goal Date is 1/4/2012
`
`0
`
`Previous actions (spectfl type and datefor each action taken)
`
`'1'
`
`Ifaccelerated approval or approval based on efficacy studies in animals, were promotional
`materials received?
`
`Note: Promotional materials to be used within 120 days after approval must have been
`submitted (for exceptions, see
`hng/www fda.gov/downloads/Drugs/GuidanceCongplianceReggilatoghifomlation/Guida
`nces/ucm069965.-d . Ifnot submitted, -
`lain
`
`l The Application Information section is (only) a checklist. The Contents of Action Package section (beginning on page 5) lists the
`documents to be included in the Action Package.
`
`Version: 809/] 1
`
`Reference ID: 3067501
`
`

`

`NDA/BLA #
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`Page 2
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`'2' Application Characteristics 2
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`[3 Priority
`IZI Standard
`Review priority:
`Chemical classification (new NDAs only):
`
`I] Fast Track
`El Rolling Review
`El Orphan drtlg designation
`
`I] Rx—to-OTC full switch
`El Rx—to—OTC partial switch
`El Direct-to—OTC
`
`NDAs: Subpart H
`El Accelerated approval (21 CFR 314.510)
`[I Restricted distribution (21 CFR 314.520)
`Subpart I
`[I Approval based on animal studies
`
`BLAs: Subpart E
`El Accelerated approval (21 CFR 601.41)
`E] Restricted distribution (21 CFR 601.42)
`Subpart H
`E] Approval based on animal studies
`
`I] Submitted in response to a PMR
`I] Submitted in response to a PMC
`El Submitted in response to a Pediatric Written Request
`
`REMS: E MedGuide
`'3 Communication Plan
`E ETASU
`El REMS not required
`Comments: REMS included Evidence of Safe Use Conditions, Implementation System, MG, Pharmacy/Healthcare Setting
`Certification, Preseriber Training or Certification
`
`'1' BLAs only: Ensure RMS—BLA Product Information Sheetfor IBP and RMS—BLA Facility
`Information Sheetfor TBP have been completed and forwarded to OPI/OBI/DRM (Vicky D Yes, dates
`Carter
`
`[I Yes D No
`
`[I Yes X No
`
`D Yes E No
`
`
`
`D None
`[I HHS Press Release
`D FDA Talk Paper
`[I CDER Q&As
`D Other
`
`
`
`0
`9.. BLAs only: Is the product subject to oflicial FDA lot release per 21 CFR 610.2
`(approvals only)
`0
`0.0 Public communications (approvals only)
`
`0 Office of Executive Programs (OEP) liaison has been notified of action
`
`0
`Press Office notified of action (by OEP)
`
`0
`
`Indicate what types (if any) of information dissemination are anticipated
`
`2 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA
`supplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA. For
`example, if the application is a pending BLA supplement, then a new RMS—BLA Product Information Sheetfor TBP must be
`completed.
`
`Version: 10/28/11
`
`Reference ID: 3067501
`
`

`

`NDA/BLA #
`
`Page 3
`
`O
`°.° Exclusivity
`
`0
`
`Is approval of this application blocked by any type of exclusivity?
`
`ENO
`
`D Yes
`
`O NDAs and BLAs: Is there existing orphan drug exclusivity for the “same”
`drug or biologic for the proposed indication(s)? Refer to 21 CFR
`31 6.3(b)(13) for the definition of "same drug”for an orphan drug (i.e.,
`active moiety). This definition is NOT the same as that usedfor ADA
`chemical classification.
`
`o
`
`(b)(2) NDAs only: Is there remaining S-year exclusivity that would bar
`efiecfive approval of a 505 (b)(2) application)? (Note that, even ifexclusivity
`remains, the application may be tentatively approved iit is otherwise ready
`for approval.)
`
`o
`
`(b)(2) NDAs only: Is there remaining 3—year exclusivity that would bar
`efiecfive approval of a 505(b)(2) application? (Note that, even ifexclusivity
`remains, the application may be tentatively approved ‘y‘it is othenvise ready
`for approval.)
`
`o
`
`(b)(2) NDAs only: Is there remaining 6—month pediatric exclusivity that
`would bar effective approval of a 505(b)(2) application? (Note that, even if
`exclusiw'ty remains, the application may be tentatively approved ifit is
`otherwise readyfor approval.)
`
`o NDAs only: Is this a single enantiomer that falls under the 10-year approval
`limitation of 505(u)? (Note that, even ifthe 10-year approval limitation
`period has not expired, the application may be tentatively approved ifit is
`otherwise readyfor approval.)
`
`‘3‘ Patent Information (NDAs only)
`
`0
`
`Patent Information:
`
`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.
`
`0
`
`Patent Certification [505(b)(2) applications]:
`Verify that a certification was submitted for each patent for the listed drug(s) in
`the Orange Book and identify the type of certification submitted for each patent.
`
` O
`
`[505(b)(2) applications] If the application includes a paragraph 111 certification,
`it cannot be approved lmtil the date that the patent to which the certification
`pertains expires (but may be tentatively approved if it is otherwise ready for
`approval).
`
`
`
`I] Yes
`E No
`If, yes, NDA/BLA #
`date exclusivity expires:
`
`
`
`If yes, NDA #
`exclusivity expires:
`
`and date
`
`D Yes
`ENO
`If yes, NDA #
`and date
`exclusivity expires:
`
`If yes, NDA #
`exclusivity expires:
`
`and date
`
`El Yes
`ENO
`If yes, NDA #
`and date 10-
`year limitation expires:
`
`IX] Verified
`D Not applicable because drug is
`an old antibiotic.
`
`21 CFR 314.50(i)(1)(i)(A)
`IZI Verified
`
`21 C1311 314.5090)
`
`D No paragraph III certification
`Date patent will expire
`
`D N/A (no paragraph IV certification)
`I] Verified
`
`o
`
`[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). (Ifthe application does not include
`any paragraph IV certifications, mark "N/A " and skip to the next section below
`(Summary Reviews)).
`
`Reference ID: 3067501
`
`Version: 10/28/11
`
`

`

` Yes
`
` No
`
` Yes
`
` No
`
` Yes
`
` No
`
` Yes
`
` No
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
`Version: 10/28/11
`
`
`
`NDA/BLA #
`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))).
`
` If “Yes,” skip to question (4) below. If “No,” continue with question (2).
`
`(2) Has the patent owner (or NDA holder, if it is an exclusive patent licensee)
`submitted a written waiver of its right to file a legal action for patent
`infringement after receiving the applicant’s notice of certification, 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 IV certification in the application, if any. If there are no other
`paragraph IV certifications, skip the rest of the patent questions.
`
`If “No,” continue with question (3).
`
`
`(3) Has the patent owner, its representative, or the exclusive patent licensee
`filed a lawsuit for patent infringement against the applicant?
`
`
`
`(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, if it is an exclusive patent licensee)
`has until the expiration of the 45-day period described in question (1) to waive
`its right to bring a patent infringement action or to bring such an action. After
`the 45-day period expires, continue with question (4) below.
`
`(4) Did the patent owner (or NDA holder, if it is an exclusive patent licensee)
`submit a written waiver of its right to file a legal action for patent
`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 IV certification in the application, if any. If there are no other
`paragraph IV certifications, skip to the next section below (Summary Reviews).
`
`If “No,” continue with question (5).
`
`
`
`
`Reference ID: 3067501
`
`

`

`NDA/BLA #
`
`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(t)(2)). Ifno written notice appears in the
`NDA file, confirm with the applicant Whether a lawsuit was commenced
`within the 45-day period).
`
`If "No, " there is no stay ofapproval based on this certification. Analyze the
`nart paragraph IV certification in the application, Vany. Ifthere are no other
`paragraph IV certifications, skip to the next section below (Summary
`Reviews).
`
`If "Yes, " a stay ofapproval may be in eflect. To determine ifa 30—month stay
`is in eflect, consult with the 0ND ADRA and attach a summary ofthe
`response.
`
`
`
`6° Copy of this Action Package Checklist3
`
`'2' List of oflicers/employees who participated in the decision to approve this application and
`consented to be identified on this list (approvals only)
`
`Documentation of consent/non-consent by oflicers/employees
`
`'2' Copies of all action letters (including approval letter withfinal labeling)
`
`Action(s) and date(s) 1/4/2012
`
`6° Package Insert (write submission/communication date at upper right offirstpage ofPI)
`
`Most recent draft labeling. Ifit is division-proposed labeling, it should be in
`track-changes format.
`
`Original applicant-proposed labeling
`
`Example of class labeling, if applicable
`
`3 Fill in blanks with dates ofreviews, letters, etc.
`
`Version: 10/28/11
`
`Reference ID: 3067501
`
`

`

`NDA/BLA #
`
`Page 6
`
`Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right offirstpage ofeach piece)
`
`Most-recent drafi labeling. Ifit is division-proposed labeling, it should be in
`track-changes format.
`
`Original applicant-proposed labeling
`
`Example of class labeling, if applicable
`
`Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right offirstpage ofeach submission)
`
`0 Most-recent draft labeling
`
`Proprietary Name
`Acceptability/non-acceptability letter(s) (indicate date(s))
`Review(s) (indicate date(s)
`Ensure that both theproprietary name(s), ifany, and the generic name(s) are
`listed in the Application Product Names section ofDARRTS, and that the
`mo rietarv/trade name is checked as the Sr erred ' name.
`
`Labeling reviews (indicate dates ofreviews and meetings)
`
`>14 Medication Guide
`[:1 Patient Package Insert
`[:1 Instructions for Use
`[:1 Device Labeling
`D None
`
`original included
`
`6/7/201 1
`
`11/8/2011, 6/7/201 1
`
`X DMIVIP 12/8/2011
`X DlVlEPA 8/29/2011
`
`x DRISK (See REMS)
`X DDTCP 12/8/2011
`
`
`
`Administrative Reviews (e.g., RPMFiling Review/Alemo ofFiling Meeting) (indicate
`date ofeach review)
`All NDA (b)(2) Actions: Date each action cleared by (b)(2) Clearance Cmte
`:505 o 2 Assessment
`indicate date)
`
`NDAs only: Exclusivity Summary (signed by Division Director)
`
`5/1 ll201 1
`
`D Not a (b)(2)
`I]
`
`l/3/2012
`l/4/2012
`
`Application Integrity Policy (AIP) Status and Related Documents
`ht_tp://www fda.gov/ICECI/EnforcementActions/ApplicationlnteE'flpolicy/defaulthtm
`
`0 Applicant is on the AIP
`
`O
`
`This application is on the AIP
`
`o Ifyes, Center Director’s Exception for Review memo (indicate date)
`
`0 Ifyes, 0C clearance for approval (indicate date ofclearance
`communication)
`
`[I Not an AP action
`
`Pediatlics (approvals only)
`0 Date reviewed by PeRC 12/7/2011
`IfPeRC review not necessary, explain:
`Pediatric Page/Record (approvals only, must be reviewed by PERC before
`nalized)
`
`0
`
`Debarmclt certification (original applications only): verified that qualifying language was
`not used in certification and that certifications from foreign applicants are cosigned by
`US. agent (include certification)
`
`X Verified, statement is
`acceptable
`
`4 Filing reviews for scientific disciplines should be filed behind the respective discipline tab.
`
`Version: 10/28/11
`
`Reference ID: 3067501
`
`

`

`NDA/BLA #
`
`Page 7
`
`Outgoing communications (letters (except action letters), emails, faxes, telecons)
`
`'2'
`
`Internal memoranda, telecons, etc.
`
`
`6° Minutes of Meetings
`
`0
`Regulatory Briefing (indicate date ofmtg)
`
`o
`Ifnot the first review cycle, any end-of-review meeting (indicate da