CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`22-264
`
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`
`
`
`
`

`

`Form Approved: OMB No. 0910-0513
`
`
`
`Department of Health and Human Services
`Expiration Date: 7/31/10
`Food and Drug Administration
`
`See 0MB Statement on Page 3.
`
`
`NBA NUMBER
`
`22-264
`
`
`
`NAME OF APPLICANTfiNDA HOLDER
`
`Ortho-McNeil-Jansscn Pharmaceuticals, Inc.
`
`
`
`
`PATENT INFORMATION SUBMITTED UPON AND
`
`AFTER APPROVAL OF AN NDA OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active ingredient), Drug Product (Formulation or
`Composition) and/or Method of Use
`
`
`
`
`
`
`
`The following is provided in accordance with Section 50505) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`TRADE NAME
`"
`
`
`
`INVEGA SUSTENNA (paliperidorle paltnitatc)
`STRENGTH(S)
`
`
`ACTIVE lNGREDIENT(S)
`'
`'
`'
`'
`39 mg, 78 mg,117 mg, 156 mg, 234 mg
`PALIPERIDONE PALMITATE
`
`
`
`APPROVAL DATE OF NDA OR SUPPLEMENT
`DOSAGE FORM
`
`
`
`31 July 2009
`
`
`Suspension for injection
`
`
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) within thirty (30) days after
`approval of an NBA or supplement or within thirty (30) days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii) at the
`
`address provided in 21 CFR 314.53(d)(4). To expedite review of this patent declaration form, you may submit an additional copy of
`
`this declaration form to the Center for Drug Evaluation and Research "Orange Book" staff.
`
`
`
`
`
`
`
`
`
`
`FDA will not list patent information if you file an incomplete patent declaration or the patent declaration indicates the patent
`is not eligible for listing.
`
`
`
`If additional space is required for any narrative answer (i.e., one that does
`For hand-written or typewriter versions of this report:
`
`not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`
`
`
`For each patent submitted for the approved MBA or supplantent referenced above, you must submit all the information
`described below. if you are not submitting any patents for this NBA or supplement. complete above section and sections 5
`and 6.
`
`1. GENERAL
`
`
`
`c. Expiration Date of Patent
`
`a. United States Patent Number
`I
`..
`b. Issue Date of Patent
`
`27 October 2010
`
`
`19 October 1993
`5,254,556
`d. Name of Patent Owner
`I
`I
`Address {of Patent Owner)
`
`
`
`Ortho—Mchil-Jansscn Pharmaceuticals, inc.
`Attn: Chief Intellectual Property Counsel, 1 125 Trenton-Harbourton Road
`
`
` CitylState
`
`Titusvillc, New Jerscy
`
`
`ZIP Code
`"M
`'
`FAXTNlumb'Er (tiavailable)
`
`0856(3—0020
`
`
`
`Telephone Number
`
`
`609-730-2000
`
`8. Name of agent or representative who resides or main-
`Address {of agent or representative named in 1.9.)
`
`
`tains a pace of Busmess Within the United States author—
`ized to receive notice of patent codification under section
`
`
`505(b)(3) and fi)(2)(8) of the Federal Food, Drug. and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (if patent
`owner or MBA applicant/holder does not reside or have a
`
`
`place of business within the United States)
`FAX Number {if available)
`jug-(jade
`
`
`I _E-Mail Address (it a vail'able) Telephone Number
`
`" '
`
`
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`Is the patent referenced above a patent that has been submitted previously for the
`.
`
`Yes
`[:1 No
`
`approved NDA or supplement referenced above?
`
`
`
`If the patent referenced above has been Isobmitted previously for listing. is the expiration
`
`Yes
`D No
`date a new expiration date?
`
`
`FORM FDA 3542 (12l08)
`Page1
`PSC Cn-apllics (30D 443-1090
`EF
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`’7 _
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`E—Mail Address'fif"available)
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`,._.._
`_
`Qty/State
`
`.
`
`

`

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`2. Drug Substance (Active Ingredient)
`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`described in the approved NDA or supplement?
`
`Yes
`
`1:! No
`
`
`
`Does the patent claim a drug substance that is a different pclymorphof the active
`ingredient described in the NDA? (See Attached Addendum)
`
`
`
`g Yes
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`X] No
`
`
`For the patent referenced above, provide the following information on each patent that claims the drug substance, drug
`
`product, or method of use that is the subject of the approved MBA or supplement. FDA will not list patent information if
`you file an incomplete patent declaration or the patent declaration indicates the patent is not eligible for listing. FDA will
`
`
`consider an incomplete patent declaration to be a declaration that does not include a response to all the questions
`
`
`contained within each section below applicable to the patent referenced above.
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`
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`
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`2.3 If the answer to question 2.2 is "Yes," do you certify that, as of the date of this declaration, you have test data
`
`
`demonstrating that a drug product containing the polymorph will perform the same as the drug product
`[:1 Yes
`D No
`described in the NBA? The type of test data required is described at 21 CFR 314.53(b).
`
`
`
`
` Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`
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`2.5 Does the patent claim only a metabolite of the approved active ingredient? (Complete the information in
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`section 4 below if the patent claims an approved method of using the approved drug product to administer
`
`the metabolite.)
`2.6
`Does the patent claim only an intermediate?
`
`
`
`[:| Yes
`No
`
`2.7 If the patent referenced in 2.1 is a product—by-process patent. is the product claimed in the
`patent novel? (An answer is required only if the patent is a product—by-prooess patent.)
`
`
`
`
`
`0
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`FDA will not list the patent in the Orange Book as claiming the drug substance if:
`. the answers to 2.1 and 2.2 are "No," or,
`' the answer to 2.2 is "Yes" and the winner to 2.3 is "No," or,
`' the answer to 2.3 is "Yes" and there is no response to 2.4, or.
`° the answer to 2.5 or 2.6 is "Yes."
`the answer to 2.7 is "No."
`
`3.2 Does the patent claim only an intermediate?
`
`
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`3. Drug Product (CompositioniFormuIation)
`
`
`3.1 Does the patent claim the approved drug product as defined in 21 CFR 314.3?
`
`
`
`
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`3.3 if the patent referenced in 3.1 is a productvhy—process patent, is the product claimed in the
`patent novel? {An answer is required only if the patent is a product—by—process patent.)
`
`
`
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`
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`
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`FDA will not list the patent in the Orange Book as claiming the drug product if:
`' the answer to question 3.1 is "No," or,
`’ the answer to question 3.2 is "Yes," or.
`‘ the answer to question 3.3 is "No."
`
`4. Method of Use
`
`
`
`Sponsors must submit the information in section 4 for each approved method of using the approved drug product claimed by the patent.
`For each approved method of use claimed by the patent, provide the following information:
`
`
`4.1 Does the patent claim one or more approved methods of using the approved drug product?
`
`
` Does (Do) the patent claim(s) referenced in 4.2 claim an
`
`4.2 Patent Claim Number(s) (as listed in the pal-em)
`
`approved method of use of the approved drug product?
`Yes
`[:I No
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`.2a If the answer to 4.2 is
`
`"Yea" identify the “39
`
`
`with specific reference to
`
`
`the approved labeling for
`the drug product.
`
`
`
`FORM FDA 3542 (12103)
`Page 2
`
`. Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`INVEGA SUSTENNA (paliperidonc palmitatc) is indicated for the acute and maintenance treatment
`.
`.
`.
`Of schizophrenia.
`
`3 4
`
`

`

`Use: (Submit the description of the approved indication or method of use that you propose FDA include as
`the "Use Code"in the Orange Book, using no more than 240 total characters including spaces.)
`U543 Treatment of Schizophrenia
`
`5. No Relevant Patents
`
`For this NDA or supplement, there are no relevant patents that claim the approved drug substance (active
`ingredient) or the approved drug product (formulation or composition) or approved method(s) of use with
`respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the
`owner of the patent engaged in the manufacture, use. or sale of the drug product.
`
`D Yes
`
`6. Declaration Certification
`
`
`4.2!: if the answer to 4.2 is
`
`
`"Yes," also provide the
`
`
`inmrmat'on on the
`Indication or method of
`use for the Orange Book
`
`
`"Use Code" description.
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`
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`
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`FDA will not list the patent in the Orange lilo—ck as claiming the method of use if:
`' the answer to question 4.1 or 4.2 is "No," or
`
`
`' if the answer to 4.2 is "Yes" and the information requested in 4.2a and 4.2b is not provided in full.
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`6.1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA or
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`supplement approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-sensitive patent
`information is submitted pursuant to 21 CFR 314.53. lattes! that i am familiar with 21' CFR 314.53 and this submission
`
`complies with the requirements of the regulation. l verify under penalty of perjury that the foregoing is true and
`correct.
`
` Warning: A willfully and knowingly false statement is a criminal offense under 18 use 1001.
`
`Date Signed
`
`
`Authorized Signature of NDA ApplicantlHoider or Patent Owner (Attorney, Agent, Representative or
`other Authorized Official) {Provide information below)
`
` L Duo. Rod ‘1
`
`HoQBuJ-ck LDe-ov‘w
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`
`
`
`NOTE: Only an NDA applicantlholder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicantl holder
`is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d}(4).
`
`
`
`Check applicable box and provide information below.
`
`Authorized Official
`fl NDA ApplicantlHolder
`pic] NDA Applicant'siHolder’s Attorney, Agent (Representative) or other
`
`Name
`
`
`Hal Brent Woodrow
`
`
`
`
`Address
`AWN—m _
`_._
`H
`7
`__
`WCitvlStEtE
`A m
`‘
`One Johnson & Johnson
`New Brunswick, New Jerey
`
`
`
`
`
`Zip Code
`M 7 77
`fl __.
`7
`Lieiephohe Number
`m v
`7'
`
`08933
`732-524-2976
`
`
`
`
`
`W Number (if availé‘ e)” r
`M
`_____...
`7
`E-Mail Address (if available)
`M"
`,
`732-524—2808
`hwo odro@its.jnj .com
`
`
`
`
`
`The public reporting hmden for this collection of information has been estimated to average 5 hours per response, including the time for reviewing instructions,
`
`searching existing data sources. gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments
`regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`
`Department of Health and Human Services
`
`Food and Drug Administration
`
`
`Office of Chief Enibrmation Ofiiccr EHFA—ilO)
`5600 Fishers Lane
`Rockvillc, MD 20857
`
`
`
`
`
`[3 Patent Owner
`
`[7] Patent Owner's Attorney. Agent (Representative) or Other Authorized
`Official
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`
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`
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`
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`
`
`
`FORM FDA 3542 (12103)
`"
`Page 3
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`An agency may not conduct or sponsor, and apersorz is not required to respond to, a collection of
`information unless it displays a currently valid OMB control number.
`
`

`

`ABDENDUM
`
`Applicant understands Question 2.2 to be asking whether the patent claims only
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`the form of the active ingredient described in the approved application. The
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`patent claims the form of the active ingredient described in the approved NBA,
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`among others and accordingly is appropriately submitted for listing.
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`

`

`EXCLUSIVITY SUMMARY
`
`
`NDA # 22-264
`
`
`
`
`
`SUPPL #
`
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`HFD # 130
`
`Trade Name: Invega Sustenna
`
`Generic Name: paliperidone palmitate extended-release injectable suspension
`
`
`
`
`
`Applicant Name: Johnson & Johnson
`
`Approval Date: July 31, 2009
`
`PART I
`
`
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`INFORMATION BELOW REFERS TO SE2-010 ONLY;
`SLR-008 DOES NOT NEED AN EXCLUSIVITY DETERMINATION.
`
`
`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
`
`
`
`505(b)(1)
`
`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
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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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`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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`Three years
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`
`
` YES
`
`
`
`NO
`
`
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`e) Has pediatric exclusivity been granted for this Active Moiety? No
`
`
`
`
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`NA
`
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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.
`
`
`2. Is this drug product or indication a DESI upgrade?
`
`
`
`
`
` YES
`
`
`
`NO
`
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`
`
` YES
`
`
`
`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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`Page 2
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`

`

`NDA#
`
` 21-999
`
` Paliperidone ER Tablets
`
`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.)
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
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`Page 3
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`NO
`
`YES
`
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`
`PART III
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of new
`clinical investigations (other than bioavailability studies) essential to the approval of the application
`and conducted or sponsored by the applicant." This section should be completed only if the answer
`to PART II, Question 1 or 2 was "yes."
`
`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
`the application contains clinical investigations only by virtue of a right of reference to clinical
`investigations in another application, answer "yes," then skip to question 3(a). If the answer to
`3(a) is "yes" for any investigation referred to in another application, do not complete remainder of
`summary for that investigation.
`
`YES
`
`
`
`NO
`
`
`
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
`

`

`
`
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`
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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?
`
`
` 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.
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`
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` YES
`
`
`
`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
`
`
`
`NO
`
`
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` If yes, explain:
`
`
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`
`
`
`
`(c)
`
`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical
`investigations submitted in the application that are essential to the approval:
`
`#1: PSY-3003
`#2: PSY-3004
`#3: SCH-201
`#4: 3007
`#5: 3001
`
`
`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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`Page 4
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`

`

`
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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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`
`
`Investigation #1
`
`Investigation #2
`
`Investigation #3
`
`Investigation #4
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`Investigation #5
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`YES
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`YES
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`YES
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`YES
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`YES
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`NO
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`NO
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`NO
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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:
`
`
`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
`
`
`
`NO
`
`
`
`Investigation #1
`
`
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`Investigation #2
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`Investigation #3
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`Investigation #4
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`Investigation #5
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`YES
`
`YES
`
`YES
`
`YES
`
`
`
`
`
`
`
`
`
`NO
`
`NO
`
`NO
`
`NO
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`If you have answered "yes" for one or more investigation, identify the NDA in which a
`imilar investigation was relied on:
`
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`Page 5
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`

`

`
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`
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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"):
`
`
`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?
`
`
`
`
`Investigation #1
`
`
`
`IND # 67,356
`
`
`
`
`
`
`
`YES
`
`
`
` NO
`
`
`
`
`
`
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`
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`
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`
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`
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`Investigation #2
`
`
`
`IND # 67,356
`
`
`
`
`
`
`Investigation #3
`
`
`
`IND # 67,356
`
`
`
`Investigation #4
`
`
`
`IND # 67,356
`
`Investigation #5
`
`
`
`IND # 67,356
`
`
`
`
`
`
`
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`
`
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`
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`YES
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`
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`YES
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`
`
`YES
`
`
`
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`YES
`
`
`
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` NO
`
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` NO
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` NO
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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?
`
`
`
` XX Not Applicable
`
`
`
`
`
`Page 6
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`

`

`If yes, explain: Not Applicable
`
`
`
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`
`
`
`YES
`
`
`
`NO
`
`
`
`
`
`
`
`
`
`(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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`
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`
`Page 7
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`

`

`=================================================================
`
`Name of person completing form:
`Title: Kimberly Updegraff, M.S.
`Date: August 3, 2009
`
`Name of Office/Division Director signing form: Thomas P. Laughren, M.D.
`Title: Director, Division of Psychiatry Products
`
`
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05
`
`
`
`
`
`Page 8
`
`

`

`Linked Applications Submission
`Type/Number
`--------------------
`--------------------
`NDA 22264
`ORIG 1
`
`NDA 22264
`
`ORIG 1
`
`Sponsor Name
`
`Drug Name / Subject
`
`--------------------
`
`------------------------------------------
`PALIPERIDONE PALMITATE 1
`MONTH INJECTION
`PALIPERIDONE PALMITATE 1
`MONTH INJECTION
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`KIMBERLY S UPDEGRAFF
`08/06/2009
`
`MITCHELL V Mathis
`08/06/2009
`For Dr. Laughren
`
`

`

`
`
` indication(s);
`
`PEDIATRIC PAGE
`(Complete for all filed original applications and efficacy supplements)
`Supplement Number: NDA Supplement Type (e.g. SE5):
`NDA/BLA#: 22-264
`
`PDUFA Goal Date: 08/03/09 Stamp Date: 2/3/2009
`Division Name:DPP HFD-130
`Invega Sustenna
`Proprietary Name:
`Established/Generic Name: paliperidone palmitatel
`IM injection
`Dosage Form:
`Applicant/Sponsor: J&J PR&D
`Indication(s) previously approved (please complete this question for supplements and Type 6 NDAs only):
`(1)
`(2)
`(3)
`(4)
`Pediatric use for each pediatric subpopulation must be addressed for each indication covered by current
`application under review. A Pediatric Page must be completed for each indication.
`Number of indications for this pending application(s):1
`(Attach a completed Pediatric Page for each indication in current application.)
`Indication: Treatment of Schizophrenia
`Q1: Is this application in response to a PREA PMR?
`Yes
`No
`
`
`
`
`
`
`
`
`
`If Yes, NDA/BLA#:
`Supplement #:
`
`Does the division agree that this is a complete response to the PMR?
` Yes. Please proceed to Section D.
`
` No. Please proceed to Question 2 and complete the Pediatric Page, as applicable.
`Q2: Does this application provide for (If yes, please check all categories that apply and proceed to the next
`question):
` active ingredient(s) (includes new combination);
`(a) NEW
`regimen; or
` route of administration?*
` No. PREA does not apply. Skip to signature block.
`(b)
`* Note for CDER: SE5, SE6, and SE7 submissions may also trigger PREA.
`Q3: Does this indication have orphan designation?
` Yes. PREA does not apply. Skip to signature block.
`
` No. Please proceed to the next question.
`
`Q4: Is there a full waiver for all pediatric age groups for this indication (check one)?
` Yes: (Complete Section A.)
`
` No: Please check all that apply:
`
` Partial Waiver for selected pediatric subpopulations (Complete Sections B)
`
` Deferred for some or all pediatric subpopulations (Complete Sections C)
`
` Completed for some or all pediatric subpopulations (Complete Sections D)
`
` Appropriately Labeled for some or all pediatric subpopulations (Complete Sections E)
`
` Extrapolation in One or More Pediatric Age Groups (Complete Section F)
`
`
` Continue
` Please proceed to Question 2.
`PMR #:
`
` dosage form;
`
` dosing
`
`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cderpmhs@fda hhs.gov) OR AT 301-796-0700.
`
`
`(b) (4)
`
`

`

`Page 2
`
`
`NDA/BLA# 22-26422-26422-26422-26422-264
`
`(Please note that Section F may be used alone or in addition to Sections C, D, and/or E.)
`Section A: Fully Waived Studies (for all pediatric age groups)
`Reason(s) for full waiver: (check, and attach a brief justification for the reason(s) selected)
` Necessary studies would be impossible or highly impracticable because:
`
` Disease/condition does not exist in children
` Too few children with disease/condition to study
` Other (e.g., patients geographically dispersed):
` Product does not represent a meaningful therapeutic benefit over existing therapies for pediatric
`patients AND is not likely to be used in a substantial number of pediatric patients.
` Evidence strongly suggests that product would be unsafe in all pediatric subpopulations (Note: if
`studies are fully waived on this ground, this information must be included in the labeling.)
` Evidence strongly suggests that product would be ineffective in all pediatric subpopulations (Note: if
`studies are fully waived on this ground, this information must be included in the labeling.)
` Evidence strongly suggests that product would be ineffective and unsafe in all pediatric
`subpopulations (Note: if studies are fully waived on this ground, this information must be included in
`the labeling.)
` Justification attached.
`If studies are fully waived, then pediatric information is complete for this indication. If there is another
`indication, please complete another Pediatric Page for each indication. Otherwise, this Pediatric Page is
`complete and should be signed.
`Section B: Partially Waived Studies (for selected pediatric subpopulations)
`Check subpopulation(s) and reason for which studies are being partially waived (fill in applicable criteria
`below):
`Note: If Neonate includes premature infants, list minimum and maximum age in “gestational age” (in weeks).
`
`
`Reason (see below for further detail):
`Not meaningful
`therapeutic
`benefit*
`
`
`0 wk. 1 mo.
` wk. mo.
` Neonate
`
`
`11 yr. 11 mo.
`0 yr. 1 mo.
` Other
`
`
` yr. mo.
` yr. mo.
` Other
`
`
` yr. mo.
` yr. mo.
` Other
`
`
` yr. mo.
` yr. mo.
` Other
` Yes.
` No;
`Are the indicated age ranges (above) based on weight (kg)?
` Yes.
` No;
`Are the indicated age ranges (above) based on Tanner Stage?
`Reason(s) for partial waiver (check reason corresponding to the category checked above, and attach a brief
`justification):
`# Not feasible:
` Necessary studies would be impossible or highly impracticable because:
`
`Disease/condition does not exist in children
`
`Too few children with disease/condition to study
`
`Other (e.g., patients geographically dispersed):
`* Not meaningful therapeutic benefit:
` Product does not represent a meaningful therapeutic benefit over existing therapies for pediatric
`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cderpmhs@fda hhs.gov) OR AT 301-796-0700.
`
`
`
`Ineffective or
`unsafe†
`
`Formulation
`failed∆
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`minimum
`
`maximum
`
`Not
`feasible#
`
`

`

`Page 3
`
`
`NDA/BLA# 22-26422-26422-26422-26422-264
`patients in this/these pediatric subpopulation(s) AND is not likely to be used in a substantial number of
`pediatric patients in this/these pediatric subpopulation(s).
`† Ineffective or unsafe:
` Evidence strongly suggests that product would be unsafe in all pediatric subpopulations (Note: if
`studies are partially waived on this ground, this information must be included in the labeling.)
` Evidence strongly suggests that product would be ineffective in all pediatric subpopulations (Note: if
`studies are partially waived on this ground, this information must be included in the labeling.)
` Evidence strongly suggests that product would be ineffective and unsafe in all pediatric subpopulations
`(Note: if studies are partially waived on this ground, this information must be included in the labeling.)
`∆ Formulation failed:
` Applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for
`this/these pediatric subpopulation(s) have failed. (Note: A partial waiver on this ground may only cover
`the pediatric subpopulation(s) requiring that formulation. An applicant seeking a partial waiver on this
`ground must submit documentation detailing why a pediatric formulation cannot be developed. This
`submission will be posted on FDA's website if waiver is granted.)
` Justification attached.
`For those pediatric subpopulations for which studies have not been waived, there must be (1) corresponding
`study plans that have been deferred (if so, proceed to Sections C and complete the PeRC Pediatric Plan
`Template); (2) submitted studies that have been completed (if so, proceed to Section D and complete the
`PeRC Pedia