CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -92 0
`
`ADMINISTRATIVE and CORRESPONDENCE
`
`'
`
`DOCUMENTS
`
`

`

`Department of Health and Human Services
`.
`.
`‘
`.
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE
`FILING OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`Form Approved: OMB NO' 0910'0513
`Expiration Date: 07/31/06
`See OMB Statement on Page 3'
`
`NDANUMBER
`
`'
`
`For'Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and
`Composition) and/or Method of Use
`
`NAME OF APPLICANT I NDA HOLDER
`Banner Pharmacaps Ine-
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`Naproxen Sodium Capsules, 220 mg
`
`ACTIVE INGREDIENT(S)
`STRENGTH(S)
`Naproxen Sodium
`220 mg
`
`-
`
`
`DOSAGE FORM
`
`Capsule (liquid filled sofi gelatin)
`
`
`
`required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`This patent declaration form is
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)( ).
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant
`to 21 CFR 314.53(c)(2)(ii) with all of
`the required information based on the approved NDA
`or supplement. The information submitted in the declaration form submitted upon or after approval will be the only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (i_e., one
`that does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`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.
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below.
`If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section-and sections 5 and 6.
`1. GENERAL
`
`
`a. United-States Patent Number [0 Expiration Date of Patent b. Issue Date of Patent
`
`
`
`
`
`Address (of Patent Owner)
`
`d. Name of Patent Owner
`
`
`
`
`
`
`City/State
`
`
`‘rAx Number (ifavailab/e)
`
`”Telephone Numbeimw "
`EZMaii Address (llavailable)
`
`
`
`
`e. Name of agent or representative who resides or maintains“ Address (of agent or i'epFeisentative named lnte.)
`a place of business within the United States authorized to
`receive notice of patent certification under section
`505(b)(3) and (j)(2)(B) of the Federal Food, Drug, and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (if patent
`owner or NDA applicant/holder does not reside or have a
`place of business within the United States)
`0'
`
`
`.
`.
`City/Stale
`
`
`ZIP Code
`FAX Number (if available)
`
`“Telephone Number ‘
`
`f.
`
`Is the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`
`9.
`
`If the patent referenced above has been submitted previously torwlisting,
`date a new expiration date?
`'
`
`is the e§<piiation
`
`FORM FDA 3542a (7/03)
`
`
`
`Page 1
`PK Mtdla Ans (J01) 4434090
`EF
`
`

`

`
`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendment, or supplement.
`
`
`2. ~ortig5$ubstanee .(Activeihgredie'riti '-
`
`
`
`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`
`described in the pending NDA, amendment, or supplement? [:i No E] Yes
`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`
`
`
`
`
`D Yesingredient described in the pending NDA, amendment, orsupplement? E] No
`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
`
`
`[:I Yes 'described in the NDA? The type of test data required is described at 21 CFR 314.53(b). [:1 No
`
`Specify the polymorphic torm(s) claimed by the patent for which you have the test results described in 2.3.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`
`
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`
`Does the patent claim only an intermediate?
`
`
`
` If the patent referenced in 2.1 is a product—by—process patent, is the product claimed in the
`
`
`
`[:I Yes
`D No
`patent novel? (An answer is required only if the patent is a product-by-process patent.)
`
`
`
`
`
`
` 3. Drug Product (Composition/For: his . *1) ,
`
`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in the pending NDA,
`
`D Yesamendment, or supplement? D No
`3.2 Does the patent claim only an intermediate?
`
`
`
`3.3
`
`if the patent referenced in 3.1 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—process patent.)
`
`D Yes
`
`D No
`
`D Yes
`
`D No
`
`4. Method of Use
`
`
`Sponsors must submit the information in section 4 separately for each patent claim claiming a method of using the pending drug
`product for which approval is being sought. For each method of use claim referenced, provide the following information:
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`
`D Yesthe pending NDA, amendment, or supplement? El No
`
`4.2 Patent Claim Number (as listed in the patent)
`Doesthe patent claim referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pending NDA,
`D No
`l amendment, or supplement?
`D Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`'
`
`4.2a If the answer to 4.2 is
`"Yes," identify with speci—
`licity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`
`5. No Relevant Patents
`
`For this pending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and 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.
`
`X Yes
`
`FORM FDA 3542a (7/03)
`
`Page 2
`PSC Media Arts (3004414090
`EF
`
`

`

`6_."DeclarationCertification
`
`6.1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA,
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent information is submitted pursuant to 21 CFR 314.53. [attest that I am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I 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 U.S.C. 1001.
`6.2 Authorized Signature of NBA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`Date Signed
`other Authorized Official) (Provide Information below)
`
`Mi:- me
`aha/05
`
`NOTE: Only an NBA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant!
`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.
`
`E NDA Applicant/Holder
`
` FAX Number (if available)
`
`l:l Patent Owner
`
`l:l Patent Owner's Attorney, Agent (Representative) or Other Authorized
`Official
`
`Name
`7
`_
`
`[:1 NBA Applicant’s/Holder’s Attorney, Agent (Representative) or other
`Authorized Official
`
`
`
`Banner Pharmacaps Inc.
`
`
`Address
`4125 Premier Drive
`
`___
`
`‘
`
`‘
`
`"
`
`_ F ‘
`
`
`City/Slate
`High Point, NC
`
`i ZIP Code
`Telephone Number
`336—812-8700 extension 3312
`l 27265
`
`E—Mail Address (ifavailable)
`336-812-9091
`skmeachum@banpharm.com
`
`
`reviewing
`including the time for
`this collection of information has been estimated to average 9 hours per response,
`The public reporting burden for
`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 ofthis collection ofinfon’nation, including suggestions for reducing this burden to:
`Food and Drug Administration
`CDER (HFD—007)
`5600 Fishers Lane
`Rockville, MD 20857
`
`An agency may no! conduct or Sponsor, and a person is not required to respond lo, a collection of
`information unimas it displays rr currently valid OMB control number.
`
`Appears This Way
`On Original
`
`FORM FDA 3542a (7/03)
`
`Page 3
`Psc Mzdla Amman-1434090
`EF
`
`9
`
`

`

`GB
`BANNERW
`505(b)(2) NDA SUBMISSION
`A mu www-
`NAPROXE’N SODIUM CAPSULES, 220 mg
`PATENT CERTIFICATION
`
`
`Patent Certification
`
`21 CFR 314.50(h)(ii), No Relevant Patents
`
`In the opinion and to the best knowledge of Banner Pharmacaps Inc., there are no patents that
`claim the drug on which investigations that are relied upon in this application were conducted or
`that claim a use of such drug.
`
`
`
`Shelly K
`Director,
`
`
`
`eachum
`
`'
`
`Date
`
`Appears This Way
`On Original
`
`10
`
`

`

`' a
`505(b)(2) NDA SUBMISSION
`BWNEE
`NAPROXEN SODIUM CAPSULES, 220 mg.
`EXCLUSIVITY
`
`
`In accordance with 21 CFR 314.500), Banner Pharmacaps Inc. does not believe that the proposed
`drug product is entitled to a period of marketing exclusivity.
`
`Appears This Way
`On Original
`
`78
`
`

`

`{Complete for all filed original applications and efficacy supplements)
`
`PEDIATRIC PAGE
`
`\lDA/BLA # :M Supplement Type (e.g. SE5):
`
`Supplement Number:
`
`Stamp Date: 4/18/05 Action Date: 2/18/06
`
`HFD56_0
`
`Trade and generic names/dosage form: naproxen sodium capsules
`
`Applicant: Banner Pharmacaps, Inc. Therapeutic Class: 5030300 NSAID
`
`Indication(s) previously approved:
`
`Each approved indication must have pediatric studies: Completed, Deferred, and/or Waived.
`
`Number of indications for this application(s):l
`
`Indication #1: Relief of minor aches and pains due to: headache, backache, muscular aches, common cold, arthritis, toothache,
`menstrual cramps, fever.
`
`Is there a full waiver for this indication (check one)?
`
`D Yes: Please proceed to Section A.
`X No: Please check all that apply: _X_Partial Waiver lDeferred _Completed
`NOTE: More than one may apply
`Please proceed to Section B, Section C, and/or Section D and complete as necessary.
`
` Section A: Fully Waived Studies
`
`Reason(s) for full waiver:
`
`DUUDU
`
`Products in this class for this indication have been studied/labeled for pediatric population
`Disease/condition does not exist in children
`
`Too few children with disease to study
`There are safety concerns
`Other:
`
`Ifstudies are fully waived, then pediatric information is completefor this indication. If there is another indication, please see
`Attachment A. Otherwise, this Pediatric Page is complete and should be entered into DFS.
`
`Section B: Partially Waived Studies
`
`I A
`
`ge/weight range being partially waived: Less than 6 months of age.
`
`Reason(s) for partial waiver:
`
`El Products in this class for this indication have been studied/labeled for pediatric population
`D Disease/condition does not exist in children
`
`Cl Too few children with disease to study
`X There are safety concerns
`D Adult studies ready for approval
`El Formulation needed
`
`X Other: The September 18, 1997, Nonprescription Drug Advisory Committee determined that labeling for pain/fever
`reducer products could safely include children down to 6 months of age, therefore the partial waiver is for ages less
`than 6 months of age.
`
`Ifstudies are deferred, proceed to Section C. Ifstudies are completed, proceed to Section D. Otherwise, this Pediatric Page is
`
`

`

`NDA 212920
`
`Page 2
`
`“amplete and should be entered into DFS.
`
`[Section C: Deferred Studies
`
`I
`
`Age/weight range being deferred: 6 months to v. years of age
`
`Reason(s) for deferral:
`
`D Products in this class for‘this indication have been studied/labeled for pediatric population
`El Disease/condition does not exist in children
`
`Cl Too few children with disease to study
`CI There are safety concerns
`Cl Adult studies ready for approval
`X Formulation needed
`Other:
`
`Date studies are due (mm/dd/yy): February 18, 2009
`
`Ifstudies are completed, proceed to Section D. Otherwise, this Pediatric Page is complete and should be entered into DFS.
`
`Section D: Completed Studies
`
`Age/weight range of completed studies: None
`
`Min
`Max
`
`kg
`kg
`
`'
`
`Comments:
`
`mo.
`mo.
`
`yr.
`yr.
`
`
`Tanner Stage
`
`Tanner Stage
`
`Ifthere are additional indications, please proceed to Attachment A. Otherwise, this Pediatric Page is complete and should be entered
`into DFS.
`
`This page was completed by:
`
`{See appended electronic signature page}
`
`Regulatory Project Manager
`
`cc: NDA 21-920
`HFD-960/ Grace Carmouze
`
`FOR QUESTIONS ON COMPLETING THIS FORM CONTACT THE DIVISION OF PEDIATRIC DRUG
`DEVELOPMENT, HFD-960, 301-594-7337.
`
`(revised 12-22-03)
`
`

`

`NDA 21-920
`
`Page 3
`
`(This attachment is to be completed for those applications with multiple indications only.)
`
`Attachment A
`
`Indication #2:
`
`Is there a full waiver for this indication (check one)? ,
`
`Cl Yes: Please proceed to Section A.
`
`Partial Waiver
`El No: Please check all that apply:
`NOTE: More than one may apply
`Please proceed to Section B, Section C, and/or Section D and complete as necessary.
`
`Deferred
`
`Completed
`
`Section A: Fully Waived Studies .,
`
`Reason(s) for full waiver:
`
`Products in this class for this indication have been studied/labeled for pediatric population
`Disease/condition does not exist in children
`
`DUUUU
`
`Too few children with disease to study
`There are safety concerns
`Other:
`
`[fstudies arefully waived, then pediatric information is completefor this indication. Ifthere is another indication, please see
`Attachment A. Otherwise, this Pediatric PageIS complete and should be entered into DFS.
`
`Section B: Partially Waived Studies
`
`Age/weight range being partially waived:
`
`' Min
`Max
`
`kg
`kg
`
`mo.
`m0.
`
`yr.
`yr.
`
`
`Tanner Stage
`
`. Tanner Stage
`
`Reason(s) for partial waiver:
`
`Products in this class for this indication have been studied/labeled for pediatric population
`Disease/condition does not exist in children
`
`DUDUDUD
`
`Too few children with disease to study
`There are safety concerns
`Adult studies ready for approval
`Formulation needed
`Other:
`
`1fstudies are deferred, proceed to Section C. Ifstudies are completed, proceed to Section D. Otherwise, this Pediatric Page is
`complete and should be entered into DFS.
`
`

`

`NDA 21-920
`
`Page 4
`
`[Section C: Deferred Studies
`
`Age/weight range being deferred:
`
`Min
`Max
`
`kg
`kg
`
`mo.
`mo.
`
`yr.
`yr.
`
`Tanner Stage
`Tanner Stage
`
`Reason(s) for deferral:
`
`I
`
`Products in this class for this indication have been studied/labeled for pediatric population
`Disease/condition does not exist in children
`
`UDUUDUD
`
`Too few children with disease to study
`There are safety concerns
`Adult studies ready for approval
`Formulation needed
`Other:
`
`Date studies are due (mm/dd/yy):
`
`Ifstudies are completed, proceed to Section D. Otherwise, this Pediatric Page is complete and should be entered into DFS.
`
`|
`
`lSection D: Completed Studies
`
`" ’
`
`'
`
`-
`
`I
`
`Age/weight range of completed studies:
`
`Min
`Max
`
`Comments:
`
`kg
`kg
`
`mo.
`mo.
`
`yr.
`yr.
`
`
`
`Tanner Stage
`Tanner Stage
`
`If there are additional indications, please copy thefields above and complete pediatric information as directed. Ifthere are no
`other indications, this Pediatric Page is complete and should be entered into DFS.
`
`This page was completed by:
`
`[See appended electronic signature page}
`
`Regulatory Project Manager
`
`cc: NDA 21—920
`HFD-960/ Grace Carmouze
`
`FOR QUESTIONS ON COMPLETING THIS FORM‘CONTACT THE DIVISION OF PEDIATRIC DRUG
`DEVELOPMENT, HFD-960, 301—594-7337.
`
`(revised 10-14-03)
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Laura Shay
`2/16/2006 04:53:38 PM
`
`Appears This Way
`On Original
`
`

`

`9
`BANNER”
`505(b)(2) NDA SUBMISSION
`A sum COMPANY
`NAPROXEN SODIUM CAPSULES, 220 mg '
`DEBARMENT CERTIFICATION
`
`
`Debarment Certification Statement
`
`\ Banner Pharmacaps 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 NDA.
`
`W/W“ .
`
`Charles Ramsburg
`Global Vice President
`
`Human Resources
`
`7%;
`
`‘
`
`Date
`
`Appears This Way
`On Original
`
`

`

`Form Approved: OMB No. 0910-0396
`
`
` Expiration Date: February 28, 2006.
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`Food and Drug Administration
`
`
`CERTIFICATION: FINANCIAL INTERESTS AND
`
`
`
`
`
`ARRANGEMENTS OF CLINICAL INVESTIGATORS
`
`TO BE COMPLETED BYAPPLICANT
`
`With respect to all covered clinical studies (or specific clinical studies listed below (if appropriate» submitted in
`support of this application,
`I certify to one of the statements below as appropriate.
`I understand that
`this
`certification is made in compliance with 21 CFR part 54 and. that for the purposes Of this statement. a clinical
`investigator includes the spouse and each dependent child of the investigator as defined in 21 CFR 54.2(d).
`
`l
`Please mark the applicable checkbox.
`I
`IE (1) As the sponsor of the submitted studies, I certify that l have not entered into any financial arrangement
`with the listed clinical investigators (enter names of clinical investigators below or attach list of names to
`this form) whereby the value of compensation to the investigator could be affected by the outcome of the
`study as defined in 21 CFR 54.2(3). I also certify that each listed clinical investigator required to disclose
`to the sponsor whether the investigator had a proprietary interest in this product or a significant equity in
`the sponsor as defined in 21 CFR 54.2(b) did not disclose any such interests.
`I further certify that no
`
`listed investigator was the recipient of significant payments of other sorts as defined in 21 CFR 54.2(f).
`
`EBma
`
`'5mu>:._,
`
`n
`
`U
`
`
`E.
`
`9.
`.E
`
`[:1 (2) As the applicant who is submitting a study or studies sponsored by a firm or party other than the
`applicant,
`I certify that based on information obtained from the sponsor or from participating clinical
`investigators, the listed clinical investigators (attach list of names to this form) did not participate in any
`financial arrangement with the sponsor of a covered study whereby the value of compensation to the
`investigator for conducting the study could be affected by the outcome of the study (as defined in 21
`CFR 54,2(a)); had no proprietary interest in this product or significant equity interest in the sponsor of
`the covered study (as defined in 21 CFR 54.2(b)); and was not the recipient of significant payments of
`other sorts (as defined in 21 CFR 54.2(f)).
`
`El (3) As the applicant who is submitting a study or studies sponsored by a firm or party other than the
`applicant,
`I certify that l have acted with due diligence to obtain from the listed clinical investigators
`(attach list of names) orfrom the sponsor the Information required under 54.4 and it was not possible to
`do so. The reason why this information could not be obtained is attached.
`
`TITLE
`
`NAME
`
`
`
`
`
`Director, Regulatory Affairs
`Shelly K. Meachum, B.Sc., RAC
`
`FIRM / ORGANIZATION
`
`Banner Pharmacaps Inc.
`
`DATE
`
`
`
`
`SIGNATURE
`4/15/05
`
`
`
`
`
`
`A M
`
`
`
`Paperwork Reduction Act Statement
`,
`I An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`information unless it displays a currently valid OMB control number. Public reporting burden for this
`collection of information is estimated to average 1 hour per response, including time for reviewing
`instructions, searching existing data sources, gathering and maintaining the necessary data, and
`completing and reviewing the collection of information. Send comments regarding this burden
`estimate or any other aspect ofthis collection ofinfonnation to the address to the right:
`
`Department Of Health and II-iumanServrces
`F°°d and Drug Administration
`5600 FishersLane, Room 14003
`Rockvrlle, MD 20857
`
`FORM FDA 3454 (2/03)
`
`Created by: PSC Media Arts Branch (3004414090 EF
`
`20
`
`

`

`NDA/EFFICACY SUPPLEMENT ACTION PACKAGE CHECKLIST
`
`NDA 21 -920
`
`Efficac Su lement Type SE-
`
`Supplement Number
`
`Phone # 301-796—0994
`
`
`
`
`
`
`: naoroxen sodium 220 m 1
` Applicant: Banner Pharmacaps Inc.
`HFD-560 Application Type: () 505(b)(1) X 505(b)(2)
`
`Listed drug(s) referred to in 505(b)(2) application (NDA #(s), Drug
`name(s)):
`NDA 20—204 Aleve® (naproxen sodium 220 mg)
`
`(This can be determined by consulting page 1 of the NDA
`Regulatory Filing Review for this application or Appendix
`A to this Action Package Checklist.)
`
`If this is a 505(b)(2) application, please review and
`confirm the information previously provided in
`Appendix B to the NDA Regulatory Filing Review.
`Please update any information (including patent
`certification information) that is no longer correct.
`
`X Confirmed and/or corrected
`
`
`pplication Classifications:
`
`
`
`
`,. X Standard ( ) Priority
`
`
`
`
`
`
`ChemclaSS<NDAson1y)
`
`Other (e.g., orphan, OTC)
`0:. User Fee Goal Dates
`o
`0.0
`
`Special programs (indicate all that apply)
`
`
`
`
`-
`
`0
`
`User Fee exception
`
`
`
` X None
`Subpart H
`( ) 21 CFR 314.510 (accelerated
`approval)
`() 21 CFR 314.520
`(restricted distribution)
`( ) Fast Track
`() Rolling Review
`( ) CMA Pilot 1
`
`
`CMA P'l t2
`
`User Fee Information
`.
`
`() Paid UF ID number
`User Fee
`
`
`
`
`
`
`
`
`"'Wsineééw'
`() Public health
`( ) Barrier-to-lnnovation
`() Other (specify)
`
`() Orphan designati
`X No-fee 505(b)(2) (see NDA
`Regulatory Filing Review for
`instructions)
`() Other (specify)
`
` Applicant”! IntegmyMMAlP),,,,, ..
`
`()Yes XNo
`Applicant is on the AIP
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`Version: 6/16/2004
`
`

`

`NDA 21—920
`
`Pagez
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`
`
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`Exception for rgyiew (Center Diregterigmgma)...
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`OC clearance for approval
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`Debarrnent certification: verified that qualifying language (e.g., willingly, knowingly) was
`
`
`
`not used in certification & certifications from forei_ an olicants are cosi; ed b US a ent.
`_
`
`‘2‘ Patent
`
`
`X Verified
`
`
`
`
`
`
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`-
`0
`
`.
`
`.
`
`21 CFR 314.50(i)(1)(i)(A)
`X Verified
`
`21 CFR 314.50(i)(1)
`
`X N/A (no paragraph IV certification)
`( ) Verified
`
`
`
`
`
`
`() Yes
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`( ) N0
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`() Yes
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`( ) No
`
`( ) Yes
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`() No
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`
`
`InformationVerifythatformFDA3542awassubmlt‘tedforpatentsthatclarm
`. the dru.g__f_9t-tth_i9h.approva1. l5..§92&l1§:_.m
`.,
`Patent certification [505(b)(2) applicatioris]: vg1;r§"';r;?;";;fiifieaagang?
`submitted for each patent for the listed drug(s) in the Orange Book and identify
`the type of certification submitted for each patent.
`
`[505(b)(2) applications] If the application includes a paragraph 111 certification, it
`cannot be approved until the date that the patent to which the certification
`pertains expires (but may be tentatively approved if it is otherwise ready for
`a oroval .
`
`
`
`
`
`
`
`
`-
`
`0
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`
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`[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). (If the application does not include
`any paragraph IV certifications, mark ”N/A ” and skip to the next box below
`(Exclusivity)).
`
`
`
`
`
`-
`
`[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 3l4.52(e))).
`
`If "Yes, " skip to question (4) below. If ”No, ”continue with question (2).
`
`(2) Has the patent owner '(or NDA holder, ifit 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 3 l4.lO7(f)(3)?
`
`If "Yes, " there is no stay ofapproval based on this certification. Analyze the next
`paragraph IV certification in the application, ifany. If there are no other
`paragraph IV certifications, skip to the next box below (Exclusivity).
`
`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?
`
`Version: 6/16/2004
`
`

`

`NDA 2 l -920
`
`Page3
`
`(Note: This can be determined by confirming whether the Division has
`received a written notice from the 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))).
`
`()Yes
`
`()NO
`
`()Yes
`
`()NO
`
`If "No, " the patent owner (or NDA holder, if it 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 314.107(i)(3)?
`
`If ”Yes, " there is no stay ofapproval based on this certification. Analyze the next
`paragraph IV certification in the application, ifany. If there are no other
`paragraph 1 V certifications, skip to the next box below (Exclusivity).
`
`If ”No, ” continue with question (5).
`
`(5) Did the patent owner, its representative, or the exclusive patent licensee
`bring suit against the 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 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 IV certification in the application, ifany.‘ If there are no other
`paragraph I V certifications, skip to the next box below (Exclusivity).
`
`If "Yes, " a stay ofapproval may be in eflect. T0 determine if a 3 0-month stay
`is in efi’ect, consult with the Director, Division ofRegulatory Policy [1, Oflice
`ofRegulatory Policy (HFD—007) and attach a summary of the response.
`
`
`
`
`
`
`
`
`
`() Yes, Application #
`X No
`
`
`
`
`
`
`
`
`‘3’ Exclusivity (approvals only)
`
`0
`0
`
`o
`
`
`
`6' Administrative Reviews (Project Manager, ADRA) (indicate date ofeach review)
`
`Version: 6/16/2004
`
`Exclusivity summary
`Is there remaining 3—year 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 ready for ap roval.)
`Is there existing orphan drug exclusivity protection for the “same drug” for the
`proposed indication(s)? Refer to 2] CFR 316.3(b)(13)for the definition of ”same
`drug"for an orphan drug (i.e., active moiety). This definition is NOT the same
`as that used for NDA chemical classi lcation.
`
`
`
`

`

`NDA21-920
`P - 4
`
`
`
`
`0
`
`Indicate what types (if any) of information dissemination are anticipated
`
`
`
`,
`
`Agency request for postmarketing commitments
`
`
`
`
`
`Proposed action
`
`XAP ()_TA()AE ()NA
`
`
`Prev1ous actions (spec1fy type and date for each action taken)
` -
`
`() Maten s requested1n AP letter_.
`
`Reviewed for Sub nart H
`0
`Status of advertising (approvals only)
`
`
`
`Publ1c commun1cat1ons
`
`
`
`
`
`Press Office notified of act1on (approval only)
`0
`() Yes X Not applicable
`
`MlX None
`
`
`
`() Press Release
`
`() Talk Paper
`
`() Dear Health Care Professional
`
`
`Letter
`Labeling (package insert, patient package insert (if applicable), MedGuide (if applicable))
`o
`Divisiciii’ s-proposed“labeling (only int—“igeneratedlatter 1511351"applicantsubmission
`
`
`_
`4
`0flabelmg)
`,
`‘
`,__
`
`l
`f Most recent applicant-proposed label1ng
`,
`,,
`,
`
`
`o
`>Or1g1nalapplicantproposed labeling
`
`
`Labeling reviews (including DDMAC DMETSDSR ) an m1nutes 619”“
`
`fig.meetings(mdzcate datesofrevzews andmeetmgs)
`
`
`- Other relevant labeling (e. g. most recent 3 in class, class label1ng)
`'2’ Labels (1mmed1ate contamer & carton labels)
`D1v151on proposed (only if generated after latest appl1cant subm1ss10n)
`.___.'. App]wampr°99§?d ,7
`,
`__
`,,
`,
`,
`
`0 Reviews
`
`,
`
`
`
`-
`
`Postmarketmg commitments
`0
`Documentation ofdiscussions and/or agreements relating topostmarketing
`0
`
`commitments _L
`_|
`
`0:0 Outgoing correspondence (i.e., letters, E-mails, faxes)
`l—X
`
`|_'1' Memoranda and Telecons X
`
`'3‘ Minutes of Meetings
`
`0
`
`EOP2 meetmg (Indicate date)
`
`
`.
`‘
`0 Pre-NDA meeting (1nd1cate date)
`0
`PreApproval Safety Conference (indicate date; approvals only)
`
`
`
`
`Advisory Committee Meeting
`
`Date of Meeting
`48-hour alert
`
`-
`
`Federal Register Notices, DESI documents, NAS/NRC reports (if applicable)
`
`Version: 6/16/2004
`
`

`

`NDA 21-920
`
`
`
`Summary Revrews (e.g., Office Director, D1v1sron Eirector, Medical Team Leader)
`
`
`indicate date or each review
`
`
`‘3’ Clinical review(s) (indicate date for each review)
`NA
`
`
`1/31/06
`
`
`
`‘2' Microbiology (efficacy) review(s) (indicate date for each review)
`
`
`
`NA
`
`
`
`‘3‘ Risk Management Plan review(s) (indicate date/location if incorporated in another rev)
`NA
`'3' Pediatric Page(separate page for each indication addressing status ofall age groups)
`12/1/05
`‘1
`
`
`‘3' Demographic Worksheet (NME approvals only)
`NA
`
`
`'1‘ Statistical review(s) (indicate datefor each review)
`NA
`
`
`'3‘ Biopharmaceutical review(s) (indicate datefor each review)
`
`2/ 1/06
`
`'1‘ Controlled Substance Staff review(s) and recommendation for scheduling (indicate date
`or each review)
`0
`
`
`Clinical Inspection Review Summary (DSI)
`Clinical studies
`
`
`
`NA
`
`
`
`
`
`o
`Bioequivalence studies
`
`
`
`2/16/06
`
`1/30/06
`
`‘2' CMC review(s) (indicate datefor each review)
`.
`Environmental Assessment
`
`
`
`
`
`
`2/ 16/06
`Categorical Exclusion (indicate review date)
`I
`J
`Review & FONSI (indicate date of review)
`0
`1
`
`
`0
`Review & Environmental Impact Statement (indicate date of each review)
`'2' Microbiology (validation of sterilization & product sterility) review(s) (indicate datefor
`
`each review)
`'1‘ Facilities inspection (provide EER report)
`
`
`
`Date completed: NA
`( ) Acceptable
`( ) Withhold recommendation
`( ) Completed NA
`( ) Requested
`Not et rec uested
`
`
`
`NA
`
`
`Pharm/tox review(s), including referenced 1ND reviews (indicate datefor each review)
`NA
`Nonclinical inspection review summary
`
`NA
`
`
`NA
`
`'1‘ Methods validation
`
`
`
`'3' Statistical review(s) of carcinogenicity studies (indicate date for each review)
`
`'3' CAC/ECAC report
`
`Version: 6/16/2004
`
`NA
`
`

`

`NDA 21-920
`
`Page 6
`
`Appendix A to NDA/Efficacy Supplement Action Package Checklist
`
`An application is likely to be a 505(b)(2) application if:
`
`(1) it relies on literature to meet any of the approval requirements (unless the applicant has a written right of
`reference to the underlying data)
`(2) it relies on the Agency's previous approval of another sponsor’s drug product (which may be evidenced
`by reference to publicly available FDA reviews, or labeling of another drug sponsor's drug pro