CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`, APPLICA TION NUMBER:
`
`21-926
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`2-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`3-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`4-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`5-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`6-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`7-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`8-118
`
`

`

`Trexima™ NDA 21-926
`
`
`
`
`Confidential
`
` Module Section Page
`1
`1.3
`9-118
`
`

`

`EXCLUSIVITY SUMMARY
`
`NDA # 21-926
`
`SUPPL #
`
`HFD # 120
`
`Trade Name Treximet Tablets
`
`Generic Name sumatriptan and naproxen sodium
`
`Applicant Name Pozen, Inc
`
`Approval Date, If Known: 4/15/08
`
`PART I
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
`
`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
`
`YES
`
`No C]
`
`Ifyes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`505(b)(2) NDA
`
`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 [I
`
`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
`
`Page 1
`
`

`

`d) Did the applicant request exclusivity?
`
`YES XI
`
`NO {:1
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`3 year
`
`e) Has pediatric exclusivity been granted for this Active Moiety?
`YES [3
`
`NO
`
`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?
`
`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 D
`
`NO
`
`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.
`Sin le active in redient
`roduct. —
`
`
`
`
`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form ofthe active moiety, e.g., this particular ester _or salt (including salts with hydrogen or
`coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has
`not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
`
`YES |:|
`
`NO D
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
`#(s),
`
`Page 2
`
`

`

`2. Combination product.
`
`approve )
`
`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 fly % 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
`d.
`
`YES
`
`NO l:|
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
`#(s).
`'
`
`NDA# 20-204
`
`Aleve (Naproxen Sodium) Tablets
`
`NDA# 18-164
`
`‘ Anaprox (Naproxen Sodium) Tablet
`
`NDA# 20-353
`
`L
`
`Naprelan (Naproxen Sodium) Controlled Release
`
`NDA#
`
`18-965
`
`Naprosyn (Naproxen Sodium) Suspension
`
`NDA# 21-920
`
`Naproxen Sodium Capsults
`
`NDA# 20-353 ~
`
`Naprelan (Naproxen Sodium) Controlled Release
`
`NDA#
`
`20-080
`
`Imitrex (sumatriptan succinate) Injection
`
`NDA#
`
`20-132 -
`
`Imitrex (sumatriptan succinate) Tablets
`
`NDA#
`
`20-626
`
`Imitrex (sumatriptan succinate) Nasal Spray
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART 11 IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`PART III
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of new
`
`Page 3
`
`

`

`clinical investigations (other than bioavailability studies) essential to the approval ofthe application
`and conducted or sponsored by the applicant." This section should be completed only ifthe answer
`to PART 11, 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 I:
`
`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 ofwhat is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
`(a) In light ofpreviously 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 ofpublished studies relevant to the safety and effectiveness
`ofthis drug product and a statement that the publicly available data would not independently
`support approval of the application?
`
`YES I]
`
`NO E
`
`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
`
`YES [:1
`
`NO [I
`
`Page 4
`
`

`

`If yes, explain:
`
`(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?
`
`YESI:I
`
`NO-
`
`If yes, explain:
`
`(c)
`
`Ifthe answers to (b)(1) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`MT400-301
`MT400-302
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`
`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer. "no.")
`-
`
`Investigation #1
`
`Investigation #2
`
`.
`
`YES E]
`
`NO E
`
`.
`
`YES El
`
`NO
`
`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NBA in which each was relied upon:
`
`Page 5
`
`

`

`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
`
`Investigation #1
`
`Investigation #2
`
`YES [3
`
`NO
`
`YES [:I
`
`NO g
`
`If you have answered "yes" for one or more investigation, identify the NBA in which a
`similar investigation was relied on:
`
`c) Ifthe 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_"):
`
`MT400-301
`MT400-3 02
`
`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(0): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`Investigation #1 — MT400—301
`
`1
`
`!
`
`IND#68,436
`
`YES
`
`1 NO D
`! Explain:
`
`Investigation #2 — MT400-302
`
`!
`
`IND#68,436
`
`YES E
`
`1
`1 NO [I
`! Explain:
`
`Page 6
`
`

`

`(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?
`
`!l
`
`!NOI:I
`Explain:
`
`!v
`
`!NOI:I
`Explain:
`
`Investigation #1
`
`YEslj
`Explain:
`
`Investigation #2
`
`YESD
`Explain:
`
`(0) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
`
`YES 1:]
`
`NO [I
`
`If yes, explain:
`
`Name of person completing form: Jacqueline H. Ware, Pharm.D.
`Title: Supervisory Regulatory Health Project Manager
`Date: July 31, 2008
`
`Name of Office/Division Director signing form: Russell Katz, M.D.
`Title: Director, Division or Neurology Products
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/ 15/05
`
`Page 7
`
`

`

`sun
`“in"
`
`9.18
`”6
`
`amum,‘
`amzwfi DEPARTMENTOFHEALTH & HUMAN SERVICES
`
`
`Food and Drug Administration
`Rockville, MD 20857
`
`PUb“° ”98”“ Service
`
`NDA 21-926
`
`DISCIPLINE REVIEW LETTER
`
`Pozen, Inc.
`Attention: Paul Ossi
`
`1414 Raleigh Road
`Suite 400
`
`Chapel Hill, NC 27517
`
`Dear Mr. Ossi:
`
`Please refer to your new drug applications (NDAs) submitted on August 8, under section 505(b)
`of the Federal Food, Drug, and Cosmetic Act for Trexima (sumatriptan naproxen) tablets.
`
`Our review of the proposed tradename ' 1’ /Treximet is complete, and we have the
`following comments:
`
`I. PROPRIETARY NAME REVIEW
`
`A. DMETS has no objections to the use of the proprietary names, gl- Freximet.
`Please note that this is considered a tentative decision and this name with its associated
`labels and labeling must be re-evaluated approximately 90 days prior to the expected
`approval of the NDA. A re-review of the name prior to NDA approval will rule out any
`objections based upon approvals of other proprietary or established names .
`B. DDMAC finds the proprietary names, — Freximet, acceptable from a
`promotional perspective.
`
`II. LABELING, PACKAGING, AND SAFETY RELATED ISSUES
`
`In the review of the container labels, carton and insert labeling of _ we have focused on
`human factors and safety issues relating to possible medication errors. We have identified the
`following areas of improvement, which might minimize potential user error.
`
`A. CONTAINER LABEL (9-c0unt)
`
`

`

`l
`
`Page(s) Withheld
`
`__ Trade Secret / Confidential
`
`_l/, Draft Labeling '
`
`.
`
`Deliberative Process
`
`Withheld Track Number: Administrative— Z a
`
`

`

`NDA 21-926
`
`Page 3
`
`D. BUSINESS REPLY CARDS
`
`We note that you have submitted additional information in the labeling submission, identified
`as ‘Business Reply Cards’. Since these items are promotional in nature, we recommend that
`you contact the Division of Drug Marketing, Advertising, and Communication regarding this
`promotional material.
`
`We are providing these comments to you before we complete our review ofthe entire application
`to give you preliminary notice of issues that we have identified. In conformance with the
`prescription drug user fee reauthorization agreements, these comments do not reflect a final
`decision on the information reviewed and should not be construed to do so. These comments are
`preliminary and subject to change as we finalize our review of your application. In addition, we
`may identify other information that must be provided before we can approve this application. If
`you respond to these issues during this review cycle, depending on the timing of your response,
`and in conformance with the user fee reauthorization agreements, we may not be able to consider
`your response before we take an action on your application during this review cycle.
`
`If you have any questions, call Lana Chen, Regulatory Management Officer, at (301) 796-1056.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, MD.
`Director
`
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Russell Katz
`12/21/2007 06:52:56 PM
`
`

`

`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21—926
`
`Pozen, Inc.
`Attention: Paul Ossi
`
`1414 Raleigh Road
`Suite 400
`
`Chapel Hill, NC 27517
`
`Dear Mr. Ossi:
`
`We acknowledge receipt on October 15, 2007 of your October 11, 2007 resubmission to your
`new drug application for sumatriptan/naproxen sodium tablets.
`
`We consider this a complete, class 2 response to our August 1, 2007 action letter. Therefore, the
`user fee goal date is April 15, 2008.
`
`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred.
`We note that you have not fulfilled the requirement. We are deferring submission of your
`pediatric studies until'April 15, 2011. However, in the interim, please submit your pediatric drug
`development plans within 120 days from the date of this letter unless you believe a waiver is
`appropriate.
`
`If you believe that this drug qualifies for a waiver of the pediatric study requirement, you should
`submit a request for a waiver with supporting information and documentation in accordance with
`the provisions of section 2 of the Pediatric Research Equity Act (PREA) within 60 days from the ‘
`date of this letter. We will notify you within 120 days of receipt of your response whether a
`waiver is granted. If a waiver is not granted, we will ask you to submit your pediatric drug
`development plans within 120 days from the date of denial of the waiver.
`
`Pediatric studies conducted under the terms of section 505A of the Federal Food, Drug, and
`Cosmetic Act may result in additional marketing exclusivity for certain products (pediatric
`exclusivity). You should refer to the Guidance for Industry on Qualifying for Pediatric
`Exclusivity (available on our web site at www.fda.gov/cder/pediatric) for details. If you wish to
`qualify for pediatric exclusivity you should submit a "Proposed Pediatric Study Request" in
`addition to your plans for pediatric drug development described above. Please note that
`satisfaction of the requirements in section 2 of PREA alone may not qualify you for pediatric
`. exclusivity.
`
`

`

`NDA 21-926
`
`Page 2
`
`If you have any question, call Lana Chen, Regulatory Project Manager, at (301) 796-1056.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, MD
`Director
`
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Russell Katz
`10/30/2007 01:59:41 PM
`
`

`

`NDA 21-926: September 25, 2007 meeting
`
`Page 1 of 2
`
`Chen, Lana Y
`
`
`
`From:
`
`Sent:
`To:
`
`Cc:
`
`Chen, Lana Y
`
`Monday, September 24, 2007 1:50 PM
`'Paul Ossi'
`
`Chen, Lana Y
`
`Subject:
`
`RE: Preliminary Comments for NDA 21-926: September 25, 2007 meeting
`
`Importance: High
`
`Attachments: N 21926 2nd AE End of Review Mtg Prelim Commentsdoc
`
`Hi Paul,
`
`Please see attached (in Word) for our preliminary comments, and confirm receipt.
`
`thanks,
`Lana
`
`From: Paul Ossi [mailtozPOssi@pozen.com]
`Sent: Thursday, September 20, 2007 4:53 PM
`To: Chen, Lana Y
`Subject: NDA 21-926: September 25, 2007 meeting
`
`Hi, Lana. With regard to our meeting scheduled for 9 am on September 25th, one person from our group,
`— cannot travel from the UK next week and so will participate in the meeting by phone. I
`am providing below the dial in numberswe wish to use at the meeting so this person can call in. The
`remainder of our group will meet with you face to face. Please let me know if there is any problem with this.
`Please also let me know the expected Agency attendees for this meeting. Thanks! See you on Tuesday.
`
`US Dial-in Number: 877-811-8957; International Dial-in Number 706-679-8003
`
`Conference Code: 919 483-5711#
`
`Regards, Paul.
`
`Paul A. 0ssi
`
`Senior Vice President, Regulatory Affairs
`
`POZEN Inc.
`
`. 1414 Raleigh Road
`
`Suite 400
`
`Chapel Hill, NC 27517
`
`9/24/2007
`
`

`

`NDA 21-926: September 25, 2007 meeting
`
`Page 2 of 2
`
`(919) 91 3- 1048 (Direct)
`
`(919) 913-1039 (Fax)
`
`Appears This Way
`On Original
`
`9/24/2007
`
`

`

`NDA 21 -926
`2nd Cycle AE-End of Review Meeting
`Preliminary Comments
`
`This material consists ofour preliminary responses to your questions and any additional comments
`in preparationfor the discussion at the meeting scheduledfor September 25, 2007 between Pozen
`and the Division ofNeurology Products.
`This material is shared to promote a collaborative and
`successful discussion at the meeting. The minutes ofthe meeting will reflect agreements, key
`issues, and any action items discussed during the formal meeting and may not be identical to these
`preliminary comments. Ifthese answers and comments are clear to you and you determine that
`further discussion is not required, you have the option ofcanceling the meeting (contact the RPM).
`Ifyou determine that discussion is neededfor only some ofthe original questions, you have the
`option ofreducing the agenda and/0r changing theformat ofthe meeting (e. g., fromface-to-face to
`telecom). Please note that ifthere are any major changes to your development plan/the purpose of
`the meeting/to the questions (based on our responses herein), we may not be prepared to discuss or
`reach agreement on such changes at the meeting. Ifany modifications to the development plan or
`additional questionsfor which you would like FDA feedback arise prior to the meeting, contact the
`Regulatory Project Manager (RPll/I) to discuss the possibility of including these for discussion at
`the meeting
`
`Because the key questions you asked can only be answered after review ofyour response to the
`approvable letter, and because such a review is beyond the scope ofan End OfReview meeting,
`we believe that no substantive discussion is possible regarding these questions, and that a
`meeting will not be useful at this time.
`
`Question #1:
`Does the Agency concur that these additional preclinical data together with specific responses to
`comments in the Approvable letter provided herewith are adequate to address the Agency’s
`concems' and that the therapeutic use of NAP/SS does not represent a genotoxic or carcinogenic
`risk?
`
`Division Response #1:
`This question cannot be answered at the present time since a response would require review of all
`relevant data. You should submit the new information, including final study reports, in a Complete
`Response to the Approvable Letter.
`
`g
`Question #2:
`If the Agency requires data in humans, does the Agency agree that the cytogenetic clinical
`evaluation with NAP/SS can be considered as a Phase 4 commitment to provide human data for
`labeling?
`
`Division Response #2:
`No. If, upon review of your response, we concur with your position that the apparent synergistic
`finding is an artifact, then the human cytogenetic study will not be needed. If we do not concur,
`then the human cytogenetic study will be needed for approval.
`
`Question #Zi:
`Does the Agency agree with the design presented, and with the definition of a negative outcome for
`the study?
`
`

`

`NDA 21-926
`2nd Cycle AE-End of Review Meeting
`Preliminary Comments
`
`Division Response #2i:
`The proposed design appears to be adequate with the exception that the drug treatments should be
`repeated daily for 7-10 days, with blood samples taken pretreatment and 24 and 48 hours after the
`final treatment. The definition of a negative outcome appears to be adequate.
`Question #Zii:
`Would a negative outcome for the clinical study serve to fully satisfy the Agency’s requirements?
`
`Division Response #2ii:
`Yes.
`
`Question #3:
`Can the Agency provide an update on the status of the review of the proposed trade name?
`
`Division Response #3
`Yes. We expect to issue a letter to you regarding the traden'ame in the next few weeks.
`
`Appears This Way
`On. Original
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Lana Chen
`9/24/2007 02:13:09 PM
`CSO
`
`

`

`Page 1 of 1
`
`Chen, Lana Y
`
`From:
`
`Chen, Lana Y
`
`Sent:
`To:
`
`Tuesday, August 28. 2007 12:07 PM
`'Paul Ossi'
`
`Cc:
`
`Chen, Lana Y
`
`Subject: NDA 21-926 MR Granted
`
`Hi Paul,
`
`Your Type A Meeting Request dated August 9, 2007 has been granted. We have tentatively scheduled
`Tuesday, Sep 25 from 9-10 am EDT. Please let me know if this will work for your group, and whether
`you intend to have a face-to-face or telecon.
`
`Please send me 10 desk copies of your meeting package at least 14 days prior to the meeting.
`
`Desk copies can be sent directly to me via FedEx, UPS or DHL at the following address:
`
`Lana Chen, RPh, Project Manager
`Division of Neurology Products
`Food and Drug Administration
`10903 New Hampshire Avenue, Building 22, Room 4353
`Silver Spring, MD 20993-0002
`
`Please also send me an electronic copy of your meeting package, including your questions, via email if
`possible.
`
`thanks,
`Lana
`
`**********************************************************************
`
`Lana Y. Chen, R.Ph., CDR-USPHS
`Senior Regulatory Project Manager
`Division of Neurology Products
`Center for Drug Evaluation and Research, FDA
`Phone 301-796-1056
`Fax 301-796-9842
`
`Email: lana.chen@fda.hhs.gov
`
`8/28/2007
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`_
`Lana Chen
`8/28/2007 12:13:12 PM
`CSO
`
`

`

`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`
`REQUEST FOR CONSULTATION
`
`
`FROM:
`TO (Division/Office):
`
`
`
`Director, Division of Medication Errors and
`
`Technical Support (DMETS), HFD-420
`ric Bastings, MD
`
`
`
`PKLN Rm. 6-34
`
`
`
`DATE
`TYPE OF DOCUMENT
`DATE OF DOCUMENT
`
`
`
`
`
`
`July 17, 2007
`Tradename Review—
`July 16, 2007
`
`{~— Treximet
`
`NAME OF DRUG
`
`
` DESIRED COMPLETION DATEPRIORITY CONSIDERATION CLASSIFICATION OF DRUG:
`
`q—v (sumatriptan and
`Migraine
`
`naproxen)
`
`NAME OF FIRM: Pozen
`
`
`
` REASON FOR REQUEST
`I. GENERAL
`
` El NEW PROTOCOL
`El PRE—NDA MEETING
`CI RESPONSE TO DEFICIENCY LETTER
`
`
`
`[3 END OF PHASE II MEETING
`El FINAL PRINTED LABELING
`El PROGRESS REPORT
`
`
`El LABELING REVISION
`El NEW CORRESPONDENCE
`El RESUBMISSION
`
`
`El DRUG ADVERTISING
`El SAFETY/EFFICACY
`El ORIGINAL NEW CORRESPONDENCE
`
`
`El ADVERSE REACTION REPORT
`El PAPER NDA
`III FORMULATIVE REVIEW
`
`
`El MANUFACTURING CHANGFJADDITION
`El CONTROL SUPPLEMENT
`IZI OTHER (SPECIFY BELOW):
`El MEETING PLANNED BY
`I
`
`
`
` II. BIOMETRICS
`
`
`STATISTICAL EVALUATION BRANCH
`STATISTICAL APPLICATION BRANCH
`
`X E
`
`Neurology Team Leader, Division of Neurology Products
`
`El TYPE A OR B NDA REVIEW
`El END OF PHASE II MEETING
`
`
`I] CONTROLLED STUDIES
`
`
`
`El PROTOCOL REVIEW
`
`
`El OTHER (SPECIFY BELOW)
`
`
`III CHEMISTRY REVIEW
`E] PHARMACOLOGY
`
`El BIOPHARMACEUTICS
`El OTHER (SPECIFY BELOW):
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`SIGNATURE OF REQUESTER
`METHOD OF DELIVERY (Check one)
`
`
`
`El MAIL
`El HAND
`Lana Chen, RPh, Project Manager 301-796-1056
`
`
`
`
`Please note the Sponsor requests review of the “(ISt choice) tradename with labels and labeling provided. See EDR for labeling.
`Desk copy with CD ROM provided also. Please note 2'"I choice1s Treximet (alternate spelling).
`
`El DISSOLUTION
`'EI BIOAVAILABILTY STUDIES
`I] PHASE IV STUDIES
`
`
`
`III. BIOPHARMACEUTICS
`
`El DEFICIENCY LETTER RESPONSE
`El PROTOCOL-BIOPHARMACEUTICS
`El
`lN-VIVO WAIVER REQUEST
`
`IV. DRUG EXPERIENCE
`
`
`
`El PHASE IV SURVEILLANCE/EPIDEMIOLOGY PROTOCOL
`El DRUG USE 6.9. POPULATION EXPOSURE, ASSOCIATED DIAGNOSES
`CI CASE REPORTS OF SPECIFIC REACTIONS (List below)
`El COMPARATIVE RISK ASSESSMENT 0N GENERIC DRUG GROUP
`
`El REVIEW OF MARKETING EXPERIENCE, DRUG USE AND SAFETY
`CI SUMMARY OF ADVERSE EXPERIENCE
`El POISON RISK ANALYSIS
`
`El CLINICAL
`
`COMMENTS, CONCERNS, andlor SPECIAL INSTRUCTIONS:
`
`V. SCIENTIFIC INVESTIGATIONS
`
`El PRECLINICAL
`
`SIGNATURE OF RECEIVER
`
`SIGNATURE OF DELIVERER
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Eric Bastings
`7/19/2007 03:00:23 PM
`
`

`

`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`
`REQUEST FOR CONSULTATION
`
`TO (Division/Office):
`
`, FROM:
`
`Director, Division of Medication Errors and
`Technical Support (DMETS), HFD—420
`PKLN Rm. 6-34
`
`X
`Eric Bastings, MD
`Neurology Team Leader, Division of Neurology Products
`
`DATE
`
`JUIY 5, 2007
`
`.
`
`TYPE OF DOCUMENT
`
`DATE OF DOCUMENT
`
`Tradename Review--
`
`July 2, 2007
`
`NAME OF DRUG
`
`PRIORITY CONSIDERATION
`
`CLASSIFICATION OF DRUG:
`
`DESIRED COMPLETION DATE
`
`' ~ (sumatriptan and
`naproxen)
`NAME OF FIRM: Pozen
`
`Migraine
`
`REASON FOR REQUEST
`
`I. GENERAL
`
`U NEW PROTOCOL
`El PROGRESS REPORT
`I:I NEw CORRESPONDENCE
`I:I DRUG ADVERTISING
`El ADVERSE REACTION REPORT
`
`I:I MANUFACTURING CHANGE/ADDITION
`:1 MEETING PLANNED BY
`
`I:I PRE-«NDA MEETING
`I:I END OF PHASE II MEETING
`I:I RESUBMISSION
`I:I SAFETY/EFFICACY
`El PAPER NDA
`
`I:I CONTROL SUPPLEMENT
`
`1
`
`1:1 RESPONSE TO DEFICIENCY LETTER
`I:I FINAL PRINTED LABELING
`I:I LABELING REVISION
`I:I ORIGINAL NEw CORRESPONDENCE
`I:I FORMULATIVE REVIEW
`
`[2] OTHER (SPECIFY BELOW:
`
`STATISTICAL EVALUATION BRANCH
`
`STATISTICAL APPLICATION BRANCH
`
`II. BIOMETRICS
`
`
`
`El TYPE A OR B NDA REVIEW
`III END OF PHASE II MEETING
`El CONTROLLED STUDIES
`[1 PROTOCOL REVIEW
`I:I OTHER (SPECIFY BELOW):
`
`El DISSOLUTION
`III BIOAVAILABILTY STUDIES
`El PHASE IV STUDIES
`
`El CHEMISTRY REVIEW
`El PHARMACOLOGY
`
`III BIOPHARMACEUTICS
`'3 OTHERISPEC'FY BELOW):
`
`III. BIOPHARMACEUTICS
`
`‘
`
`CI DEFICIENCY LETTER RESPONSE
`El PROTOCOL-BIOPHARMACEUTICS
`III
`IN-VIVO WAIVER REQUEST
`
`IV. DRUG EXPERIENCE
`
`III PHASE IV SURVEILLANCE/EPIDEMIOLOGY PROTOCOL
`El DRUG USE e.g. POPULATION EXPOSURE, ASSOCIATED DIAGNOSES
`El CASE REPORTS OF SPECIFIC REACTIONS (List below)
`El COMPARATIVE RISK ASSESSMENT ON GENERIC DRUG GROUP
`
`El REVIEW OF MARKETING EXPERIENCE, DRUG USE AND SAFETY
`El SUMMARY OF ADVERSE EXPERIENCE
`E] 'POISON RISK ANALYSIS
`
`El CLINICAL
`
`V. SCIENTIFIC INVESTIGATIONS
`
`III PRECLINICAL
`
`COMMENTS, CONCERNS, and/or SPECIAL INSTRUCTIONS:
`Please note the Sponsor requests review of the ' tradename with labels and labeling provided . See EDR for labeling. Desk copy
`with CD ROM) provided also.
`~
`
`SIGNATURE OF REQUESTER
`Lana Chen, RPh, Project Manager 301 -796-1 056
`
`METHOD OF DELIVERY (Check one)
`'3 MA'L
`
`SIGNATURE OF RECEIVER
`
`SIGNATURE OF DELIVERER
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Eric Bastings
`7/10/2007 03:03:00 PM
`
`

`

`Q“
`
`“W70 '
`45'”
`Q’
`
`«9
`
`g5 _( DEPARTMENTOF HEALTH&HUMAN SERVICES
`
`4%
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21 -926
`
`Pozen, Inc.
`Attention: Paul Ossi
`
`1414 Raleigh Road
`Suite 400
`
`Chapel Hill, NC 27517
`
`Dear Mr. Ossi:
`
`We acknowledge receipt on February 1, 2007 of your January 31, 2007 resubmission to your
`new drug application for Trexima (sumatriptan/naproxen) tablets.
`
`We consider this a complete, class 2 response to our June 8, 2006 action letter. Therefore, the
`user fee goal date is August 1, 2007.
`
`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred.
`We note that you have not fulfilled