CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`203752Orig1s000
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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 # 203752
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`EXCLUSIVITY SUMMARY
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`SUPPL #
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`HFD #
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`Trade Name Minivelle
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`Generic Name estradiol transdermal system
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`Applicant Name Noven Pharmaceuticals, Inc.
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`Approval Date, If Known October 29, 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)(1)
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`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
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` YES
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`NO
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`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
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`The NDA was supported by a bioequivalence and a dose proportionality study (both
`bioavailability studies). Both studies measured the rate and extent to which the active
`ingredient/active moiety was absorbed.
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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: 3209614
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`Page 1
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`d) Did the applicant request exclusivity?
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`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
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` YES
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`NO
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`e) Has pediatric exclusivity been granted for this Active Moiety?
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` YES
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`NO
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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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`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).
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`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
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`1. Single active ingredient product.
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`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: 3209614
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`Page 2
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`NDA# See attached sheet
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`NDA#
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`NDA#
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
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`Reference ID: 3209614
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`Page 3
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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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`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."
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`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
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`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
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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
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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:
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`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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` YES
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`NO
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`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
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` If yes, explain:
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` YES
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`NO
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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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`Reference ID: 3209614
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`Page 4
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` If yes, explain:
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` YES
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`NO
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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.
`
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`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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`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`The Phase 3 trials (1003-A and 1003-B) conducted under Vivelle NDA 20323 and
`the Phase 4 trial (Protocol 036) submitted April 30, 1999 and approved on February 25, 2000
`under Supplement 21 of Vivelle NDA 20323.
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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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`YES
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`NO
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`Investigation #1
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`Reference ID: 3209614
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`Page 5
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`Investigation #2
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`YES
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`NO
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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"):
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`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.
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`Investigation #1
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`YES
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` NO
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`Investigation #2
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` Explain:
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`YES
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` NO
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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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`Reference ID: 3209614
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`Page 6
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`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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` Explain:
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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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` NO
` Explain:
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` NO
` Explain:
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`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
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`YES
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`NO
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`If yes, explain:
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`
`
`=================================================================
`
`Name of person completing form: Samantha Bell
`Title: Regulatory Health Project Manager
`
`
`
`Name of Office/Division Director signing form: Hylton Joffe
`Title: Division Director
`
`
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
`List of approved drug products containing the active moiety:
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`N021674 MENOSTAR
`N020375 CLIMARA
`N020538 VIVELLE-DOT
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`Reference ID: 3209614
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`Page 7
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`N020323 VIVELLE
`N019081 ESTRADERM
`N020655 ALORA
`N021166 ESTROGEL
`N021813 ELESTRIN
`N022038 DIVIGEL
`N020472 ESTRING
`N022014 EVAMIST
`N020908 VAGIFEM
`
`There are also several approved products containing ETHINYL ESTRADIOL, ESTRADIOL
`ACETATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL
`VALERATE.
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`
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`Reference ID: 3209614
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`Page 8
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`

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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/
`----------------------------------------------------
`
`SAMANTHA S BELL
`11/13/2012
`
`HYLTON V JOFFE
`11/13/2012
`
`Reference ID: 3209614
`
`

`

`1.3. Administrative Information
`
`3.
`
`DEBARMENT CERTIFICATION
`
`Noven Pharmaceuticals, Inc. 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”. Way—.—
`
`Sean M. Russell
`
`Associate Director, Regulatory Affairs
`
`\SQEL 20)\
`
`Date
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`

`

`Bell, Samantha
`
`l=rom:
`:nt:
`I‘o:
`Cc:
`Subject:
`
`Hi Samantha,
`
`Greeley, George
`Monday, October 15, 2012 11:58 AM
`Bell, Samantha
`Suggs, Courtney
`RE: NDA 203752 Sept 19 PeRC meeting
`
`It was found during the review at PeRC on September 19th that NDA 23-752 Estradiol
`Transdermal System product did not trigger PREA.
`
`No further action is necessary from the Division for this product as it relates to the PeRC and
`PREA.
`
`Thank you.
`George Greeley
`
`George Greeley
`Regulatory Health Project Manager
`Pediatric and Maternal Health Staff
`
`FDA/CDER/OND
`
`10903 New Hampshire Avenue
`'dg. 22, Room 6467
`Silver Spring, MD 20993-0002
`Phone: 301.796.4025
`
`Email: george. greeley@fda.hhs. gov
`® Please consider the environment before printing this e-mail.
`
`From:
`Sent:
`To:
`Subject:
`
`Bell, Samantha
`Friday, October 12, 2012 11:48 AM
`Suggs, Courtney; Greeley, George
`NDA 203752 Sept 19 PeRC meeting
`
`Hi Courtney and George,
`I’m following up from the Sept 19 PeRC meeting when it was determined that NDA 203752 did not trigger PREA.
`
`The Division would like to document the discussion at the meeting. Could you forward the minutes or respond to this email
`to confirm that no further action is necessary from the Division and as I understand the requirement is inapplicable for this
`application?
`
`Thanks,
`Samantha
`
`Samantha Bell, BS, BA, RAC
`“egulatory Health Project Manager
`)A/Center for Drug Evaluation and Research
`Division of Reproductive and Urologic Products
`W022 - Room 5379
`
`10903 New Hampshire Avenue
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`

`

`ACTION PACKAGE CHECKLIST
`
`APPLICATION INFORMATION1
`
`NDA # 203752
`BLA #
`
`NDA Supplement #
`BLA Supplement #
`
`_
`IfNDA, Efficacy Supplement Type.
`
`Proprietary Name: Minivelle
`Established/Proper Name: estradiol transdermal system
`Dosage Form:
`film, extended release
`
`Appllcant: Noven Pharmaceuticals, Inc.
`Agent for Applicant (if applicable):
`
`RPM: Samantha Bell
`
`Division: Division of Reproductive and Urologic Products
`
`NDAs and NDA Efficacy Supplements:
`
`505(b)(2) Original NDAs and 505(b)(2) NDA supplements:
`
`NDA Application Type:
`Efficacy Supplement:
`
`505(b)(1) El 505(b)(2) Listed drug(s) relied upon for approval (include NDA #(s) and drug
`E] 505(b)(1) E] 505(b)(2)
`name(s)):
`
`(A supplement can be either a (b)(l) or a (b)(2)
`regardless of whether the original NDA was a (b)(l)
`or a (b)(2). Consult page 1 of the 505(b)(2)
`Assessment or the Appendix to this Action Package
`Checklist.)
`
`Provide a brief explanation of how this product is different from the listed
`drug.
`
`El This application does not reply upon a listed drug.
`[:1 This application relies on literature.
`D This application relies on a final OTC monograph.
`I: This application relies on (explain)
`
`For ALL (b)(2) applications, two months prior to EVERY actiona
`review the information in the 505(b)(2) Assessment and submit the
`draft2 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.
`
`E] 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.
`
`
`
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`
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`0v
`
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`Actions
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`0
`Proposed action
`
`0 User Fee Goal Date is October 29 2012
`
`
`
` 0
`Previous actions (specify type and datefor each action taken)
`
`
`
`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.
`2 For resubmissions, (b)(2) applications must be cleared before the action, but it is not necessary to resubmit the draft 505(b)(2)
`Assessment to CDER 0ND 10 unless the Assessment has been substantively revised (e.g., nrew listed drug, patent certification
`revised).
`
`Version: 1/27/12
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`

`

`NDA/BLA #
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`Page 2
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`‘2’
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`If accelerated 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
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
`nces/ucm069965pdf). If not submitted, explain
`
`E] Received
`
`'2' Application Characteristics 3
`
`[:J Priority
`IX Standard
`Review priority:
`Chemical classification (new NDAs only):
`
`5
`
`[:1 Fast Track
`[I Rolling Review
`[I Orphan drug designation
`
`D Rx-to-OTC full switch
`E] Rx-to-OTC partial switch
`El Direct-to-OTC
`
`NDAs: Subpart H
`|:] Accelerated approval (21 CFR 314.510)
`I: Restricted distribution (21 CFR 314.520)
`Subpart I
`[I Approval based on animal studies
`
`BLAs: Subpart E
`CI Accelerated approval (21 CFR 601.41)
`D Restricted distribution (21 CFR 601.42)
`Subpart H
`I] Approval based on animal studies
`
`|:I Submitted in response to a PMR
`[I Submitted in response to a PMC
`I] Submitted in response to a Pediatric Written Request
`
`Comments:
`
`REMS: I:] MedGuide
`I] Communication Plan
`I: ETASU
`E] MedGuide w/o REMS
`{XI REMS not required
`
`‘3‘ BLAs only: Ensure RMS—BLA Product Information Sheetfor TBP and RMS—BLA Facility
`Information Sheetfor TBP have been completed and forwarded to OPI/OBI/DRM (Vicky
`Carter)
`
`[I Yes, dates
`
`'3' BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
`
`D Yes
`
`I] No
`
`
`
`4' Public communications (approvals only)
`
`0
`
`0
`
`0
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`Office of Executive Programs (OEP) liaison has been notified of action
`
`Press Office notified of action (by OEP)
`
`Indicate what types (if any) of information dissemination are anticipated
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`Yes D No
`
`E Yes El No
`
`Other
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`IX] None
`HHS Press Release
`III
`E FDA Talk Paper
`El
`CDER Q&As
`El
`
`
`
`3 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA
`ipplement, 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: 1/27/ 12
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`

`

`NDA/BLA #
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`Page 3
`
`‘
`9 Exclusivity
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`0
`
`Is approval of this application blocked by any type of exclusivity?
`
`0 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 NDA
`chemical classification.
`
`E] Yes
`If, yes, NDA/BLA #
`date exclusivity expires:
`
`and
`
`0
`
`0
`
`0
`
`(b)(2) NDAs only: Is there remaining 5-year exclusivity that would bar
`effective approval of a 505(b)(2) application)? (Note that, even ifexclusivity
`remains, the application may be tentatively approved ifit is otherwise ready
`for approval.)
`
`C] No
`If yes, NDA #
`exclusivity expires:
`
`I:] Yes
`and date
`
`(b)(2) NDAs only: Is there remaining 3-year exclusivity that would bar
`effective approval of a 505(b)(2) application? (Note that, even ifexclusivity
`remains, the application may be tentatively approved if it is otherwise ready
`for approval.)
`
`I:] No
`If yes, NDA #
`exclusivity expires:
`
`D Yes
`and date
`
`(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
`exclusivity remains, the application may be tentatively approved if it is
`otherwise readyfor approval.)
`
`C] No
`If yes, NDA #
`exclusivity expires:
`
`El Yes
`and date
`
`
`
`Is this a single enantiomer that falls under the 10—year approval
`0 NDAs only:
`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.)
`
`I:] Yes
`IE No
`and date 10-
`If yes, NDA #
`year limitation expires:
`
`
`
`
`‘2‘ 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.
`
`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.
`
`0
`
`0
`
`0
`
`[505(b)(2) applications] If the application includes a paragraph III certification,
`it cannot be approved until the date that the patent to which the certification
`E] No paragraph 111 certification
`pertains expires (but may be tentatively approved if it is otherwise ready for
`Date patent will expire
`approval).
`
`
`[505(b)(2) applications] For each paragraph IV certification, verify that the
`applicant notified the NDA holder and patent owner(s) of its certification that the
`patent(s) is invalid, unenforceable, or will not be infiinged (review
`documentation of notification by applicant and documentation of receipt of
`notice by patent owner and NDA holder). (Ifthe application does not include
`any paragraph IV certifications, mark “N/A ” and skip to the next section below
`(Summary Reviews)).
`
`D N/A (no paragraph IV certification)
`Verified
`D
`
`Verified
`
`[I Not applicable because drug is
`an old antibiotic.
`
`
`
`|:I (ii) Cl
`
`(iil)
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`Version: 1/27/12
`
`

`

`NDA/BLA #
`
`Page 4
`
`[...........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
`
`o
`
`[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
`infiingement after receiving the applicant’s notice of certification, as
`provided for by 21 CFR 314.107(t)(3)?
`
`If “Yes, ” there is no stay ofapproval based on this certification. Analyze the next
`paragraph IV certification in the application, ifany. Ifthere are no other
`paragraph IV certifications, skip the rest ofthe patent questions.
`
`If “No, ” continue with question (3).
`
`E] Yes
`
`D No
`
`[:1 Yes
`
`El No
`
`
`
`(3) Has the patent owner, its representative, or the exclusive patent licensee
`filed a lawsuit for patent infringement against the applicant?
`
`E] Yes
`
`D No
`
`(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))).
`
`If “No, ” the patent owner (or NDA holder, ifit is an exclusive patent licensee)
`has until the expiration ofthe 45-day period described in question (I) to waive
`its right to bring a patent infringement action or to bring such an action. After
`the 45—day period expires, continue with question (4) below.
`
`(4) Did the patent owner (or NDA holder, if it is an exclusive patent licensee)
`submit a written waiver of its right to file a legal action for patent
`infringement within the 45-day period described in question (1), as
`provided for by 21 CFR 314.lO7(t)(3)?
`
`E] Yes
`
`E] No
`
`If ”Yes, ” there is no stay ofapproval based on this certification. Analyze the next
`paragraph IV certification in the application, ifany. Ifthere are no other
`paragraph IV certifications, skip to the next section below (Summary Reviews).
`
`If “No, ” continue with question (5).
`
`
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`' Version: 1/27/12
`
`

`

`El Yes
`
`[:I No
`
`
`
`(5) Did the patent owner, its representative, or the exclusive patent licensee
`bring suit against the (b)(2) applicant for patent infidngement within 45
`days of the patent owner’s receipt of the applicant’s notice of
`certification?
`
`(Note: This can be determined by confirming whether the Division has
`received a written notice from the (b)(2) applicant (or the patent owner or
`its representative) stating that a legal action was filed within 45 days of
`receipt of its notice of certification. The applicant is required to notify the
`Division in writing whenever an action has been filed within this 45-day
`period (see 21 CFR 314.107(f)(2)). If no written notice appears in the
`NDA file, confirm with the applicant whether a lawsuit was commenced
`within the 45-day period).
`
`If “No, ” there is no stay ofapproval based on this certification. Analyze the
`next paragraph IVcertification in the application, ifany. Ifthere are no other
`paragraph 1V certifications, skip to the next section below (Summary
`Reviews).
`
`If “Yes, ” a stay ofapproval may be in effect. T0 determine ifa 30-month stay
`is in eflect, consult with the 0ND ADRA and attach a summary ofthe
`response.
`
`
`
`
`’9 Copy of this Action Package Checklist4
`
`Included
`
`CONTENTS OF ACTION PACKAGE
`
`
`
`Officer/Employee List
`
`
`List of officers/employees who participated in the decision to approve this application and E Included
`consented to be identified on this list (approvals only)
`
`
`
`Documentation of consent/non—consent by officers/employees
`
`IX| Included
`
`0 v
`
`'1‘ Copies ofall action letters (including approval letter withfinal labeling)
`
`85%;;639 2012
`
`Action Letters
`
`_
`
`Labeling
`
`
`
`’2' Package Insert (write submission/communication date at upper right offirstpage ofPI) —
`
`g Included Final PI
`
`
`12—29-2011IZ Included
`
`
`0
`
`Example of class labeling, if applicable
`
`0 Original applicant-proposed labeling
`
`4 Fill in blanks with dates of reviews, letters, etc.
`
`Version: 1/27/ 12
`
`Reference ID: 3215297
`Reference ID: 3215297
`
`

`

` Medication Guide
`Patient Package Insert
`
`
`
`[3 Instructions for Use
`
`
`E] Device Labeling
`I None
`
`
`
` Included Final PI
`
`December29, 201 1
`
`NDA/BLA #
`
`Page 6
`
`.' Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right offirst page ofeach piece)
`
`0 v
`
`0 Most-recent drafi labelmg Ifit is d1v1s1on-proposed labeling,it should be1n
`track-changes format
`
`Example ofclass labeling, ifapplicable
`
`
`Labels (full color carton and immediate-container labels) (write
`
`
`
`submisswn/commumcation date on upper right offrst page ofeachsubmission)
`
`
`
`
`0 Most-recent drafi labeling
`
`
`
`
`Acceptable:
`
`
`
`
`0:0 Proprietary Name
`Minivelle — August 7, 2012,
`0 Acceptability/non-acceptability letter(s) (indicate date(s))
`
`
`
`August 8,2012
`
`
`
`0
`Review(s) (indicate date(s)
`Unacceptable:
`
`
`April 4, 2012, April 5,
`0
`Ensure that both the proprietary name(s), ifany, and the generic name(s) are
`
`
` 2012
`
`listed in the Application Product Names section ofDARR TS, and that the
`
`proprietary/trade name is checked as the 'preferred ’ name.
`
`
`
`
`
`[I RPM
`IX] DMEPA October 26, 2012
`
`DMPP/PLT (DRISK) October
`
`1,2012
`ODPD(DDMAC) October 9,
`
`2012; October 23, 2012
`SEALD October 26, 2012;
`
`October 29, 2012
`13 CSS
`[3 Other reviews
`
`
`
`'3’ Labeling reviews (indicate dates ofreviews and meetings)
`
`
`
`
`
`
`
`
`
`Administrative / Regulatory Documents
`
`
`
`
`
`'3 Administrative Reviews (e.g., RPM Filing Review /Memo ofFiling Meeting) (indicate
`date ofeach review)
`'3' All NDA (b)(2) Actions: Date each action cleared by (b)(2) Clearance Cmte
`#0 NDA b 2 A- rovals Onl
`: 505 b 2 Assessment (indicate dale)
`
`Included April 16, 2012
`K4
`
`
`
`
`
`X] Not a (b)(2)
`IX Not a (b)(2)
`
`'1‘ NDAs only: Exclusivity Summary (signed by Division Director)
`
`E] Included
`
`1:] Yes No.
`Cl Yes E No
`
`'3' Application Integrity Policy (AIP) Status and Related Documents
`
`
`
`htztp//www. fda"govICECI/EnforcementActions/Applcanonlntegntyl’ol1cy/defaulthtm
`-
`Appl1cant1s on the AIP
`This application1s on theAIP
`0
`If yes, Center Director' s Exception for Review memo (indicate date)
`
` -
`
`0
`
`If yes, 0C clearance for approval (indicate date ofclearance
`communication)
`
`Cl Not an AP action
`
`5 Filing reviews for scientific disciplines should be filed behind the respective discipline tab.
`
`Version: ”27/12
`
`Reference ID: 321 5297
`
`

`

`NDA/BLA #
`
`Page 7
`
`‘1‘ Pediatrics (approvals only)
`0
`Date reviewed by PeRC
`If PeRC review not necessary, explain: Does not trigger PREA
`Pediatric Page/Record (approvals only, must be reviewed by PERC before
`finalized)
`
`0
`
`I: Included
`
`6' Debarment certification (original applications only): verified that qualifying language was
`not used in certification and that certifications from foreign applicants are cosig