CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`205103Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`EXCLUSIVITY SUMMARY
`
`
`NDA # 205103
`
`
`
`
`
`SUPPL #
`
`
`
`
`
`HFD # 180
`
`Trade Name Yosprala delayed-released Tablets
`
`Generic Name aspirin 81 mg/omeprazole 40 mg, and aspirin 325 mg/omeprazole 40 mg
`
`
`
`
`
`Applicant Name Aralez Pharmaceuticals R&D Inc.
`
`Approval Date, If Known 09/14/2016
`
`PART I
`
`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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`
`
`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`
`
`505(b)(2)
`
`b) 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.
`
`
`
`
`
`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:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3985744
`
`Page 1
`
`

`

`c) Did the applicant request exclusivity?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`
`3 years
`
`
`
`d) Has pediatric exclusivity been granted for this Active Moiety?
`
`
` YES
`
`
`
`NO
`
`
`
`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
`
`
`
`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. 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.
`
`
`
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`
`
`
`
`
`
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`
`Reference ID: 3985744
`
`
`
`Page 2
`
`

`

`NDA#
`
`
`
`NDA#
`
`
`
`NDA#
`
`
`
`
`
`
`
`
`
`
`
`
`
`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.)
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`See attachment.
`
`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
`
`
`
`Reference ID: 3985744
`
`Page 3
`
`

`

`
`
`
`
`
`
`(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?
`
`
`(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
`
`
`
`NO
`
`
`
`
`
`
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
` If yes, explain:
`
`
`
`
`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.
`
`
`(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
`
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`
`
`NO
`
`
`
`
`(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?
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`
`
` If yes, explain:
`
`
`
`
`
`
`
`
`(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:
`
`
`
`Reference ID: 3985744
`
`Page 4
`
`

`

`Study 1: PA32540-301
`Study 2: PA32540-302
`
`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
`
`YES
`
`
`
`
`
`NO
`
`NO
`
`
`
`
`
`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`Not applicable
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
`
`Study 1: PA32540-301
`
`
`
`Reference ID: 3985744
`
`Page 5
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation #1
`
`Investigation #2
`
`
`
`
`
`
`
`
`
`
`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?
`
`
`
`
`
`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`
`
`
`
`
`
`
`
`YES
`
`YES
`
`
`
`
`
`NO
`
`NO
`
`
`
`
`
`

`

`Study 2: PA32540-302
`
`
`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?
`
`
`!
`
`! NO
`! Explain:
`
`
`
`!
`
`
`
`
`Investigation #1: PA32540-301
`
`
`
`
`
`IND # 78,747
`YES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation #2: PA32540-302
`
`IND # 78,747
`
`
`
`
`
`
`YES
`
`
`
`
`
`
`!
`
`
`
`
`!
`
`! NO
`! Explain:
`
`(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?
`
`Investigation #1
`
`
`
`
`
`
`
`
`
`YES
`Explain:
`
`
`Investigation #2
`
`
`YES
`Explain:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`
`
`
`Reference ID: 3985744
`
`Page 6
`
`

`

`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
`
`
`
`NO
`
`
`
`If yes, explain:
`
`
`
`
`
`
`
`
`=================================================================
`
`Name of person completing form: CAPT Mimi T. Phan
`Title: Regulatory Project Manager
`Date: 09/12/2016
`
`
`Name of Division Director signing form: Donna Griebel
`Title: Division Director
`
`
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
`
`
`
`
`Reference ID: 3985744
`
`Page 7
`
`

`

`Attachment for Part II Question #2
`
`
`
`NDA#
`
`BRAND NAME
`
`GENERIC NAME
`
`DOSAGE FORM
`
`N007337
`
`PERCODAN
`
`N007337
`
`PERCODAN
`
`N007337
`
`PERCODAN-DEMI
`
`ASPIRIN; OXYCODONE
`HYDROCHLORIDE
`
`ASPIRIN; OXYCODONE
`HYDROCHLORIDE; OXYCODONE
`TEREPHTHALATE
`
`ASPIRIN; OXYCODONE
`HYDROCHLORIDE; OXYCODONE
`TEREPHTHALATE
`
`N010996
`
`DARVON COMPOUND
`
`N010996
`
`DARVON COMPOUND-
`65
`
`ASPIRIN; CAFFEINE;
`PROPOXYPHENE
`HYDROCHLORIDE
`
`ASPIRIN; CAFFEINE;
`PROPOXYPHENE
`HYDROCHLORIDE
`
`N010996
`
`DARVON W/ ASA
`
`ASPIRIN; PROPOXYPHENE
`HYDROCHLORIDE
`
`TABLET
`
`TABLET
`
`TABLET
`
`CAPSULE
`
`CAPSULE
`
`CAPSULE
`
`N011483
`
`SYNALGOS-DC
`
`ASPIRIN; CAFFEINE;
`DIHYDROCODEINE BITARTRATE
`
`CAPSULE
`
`N011702
`
`N012281
`
`N012365
`
`N012366
`
`EQUAGESIC
`
`ROBAXISAL
`
`ASPIRIN; MEPROBAMATE
`
`ASPIRIN; METHOCARBAMOL
`
`SOMA COMPOUND
`
`ASPIRIN; CARISOPRODOL
`
`SOMA COMPOUND W/
`CODEINE
`
`ASPIRIN; CARISOPRODOL;
`CODEINE PHOSPHATE
`
`N013416
`
`NORGESIC
`
`N013416
`
`NORGESIC FORTE
`
`ASPIRIN; CAFFEINE;
`ORPHENADRINE CITRATE
`
`ASPIRIN; CAFFEINE;
`ORPHENADRINE CITRATE
`
`N016030
`
`8-HOUR BAYER
`
`ASPIRIN
`
`N016030
`
`MEASURIN
`
`ASPIRIN
`
`TABLET
`
`TABLET
`
`TABLET
`
`TABLET
`
`TABLET
`
`TABLET
`
`TABLET, EXTENDED
`RELEASE
`
`TABLET, EXTENDED
`RELEASE
`
`N016829
`
`DARVON-N W/ ASA
`
`ASPIRIN; PROPOXYPHENE
`
`CAPSULE
`
`Reference ID: 3985744
`
`

`

`Attachment for Part II Question #2
`
`
`
`N016863
`
`DARVON-N W/ ASA
`
`N016891
`
`TALWIN COMPOUND
`
`NAPSYLATE
`
`ASPIRIN; PROPOXYPHENE
`NAPSYLATE
`
`ASPIRIN; PENTAZOCINE
`HYDROCHLORIDE
`
`TABLET
`
`TABLET
`
`FIORINAL
`
`FIORINAL
`
`ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE
`
`ASPIRIN; BUTALBITAL; CAFFEINE TABLET
`
`FIORINAL W/CODEINE ASPIRIN; BUTALBITAL; CAFFEINE;
`CODEINE PHOSPHATE
`
`CAPSULE
`
`EXCEDRIN (MIGRAINE) ACETAMINOPHEN; ASPIRIN;
`CAFFEINE
`
`N020884
`
`AGGRENOX
`
`ASPIRIN; DIPYRIDAMOLE
`
`N017534
`
`N017534
`
`N019429
`
`N020802
`
`N021317
`
`N021387
`
`N021387
`
`N021387
`
`N021387
`
`N021387
`
`N021387
`
`TABLET
`
`CAPSULE,
`EXTENDED
`RELEASE
`
`TABLET
`
`BAYER EXTRA
`STRENGTH ASPIRIN
`FOR MIGRAINE PAIN
`
`ASPIRIN
`
`PRAVIGARD PAC
`(COPACKAGED)
`
`PRAVIGARD PAC
`(COPACKAGED)
`
`PRAVIGARD PAC
`(COPACKAGED)
`
`PRAVIGARD PAC
`(COPACKAGED)
`
`PRAVIGARD PAC
`(COPACKAGED)
`
`PRAVIGARD PAC
`(COPACKAGED)
`
`ASPIRIN; PRAVASTATIN SODIUM
`
`TABLET, TABLET
`
`ASPIRIN; PRAVASTATIN SODIUM
`
`TABLET, TABLET
`
`ASPIRIN; PRAVASTATIN SODIUM
`
`TABLET, TABLET
`
`ASPIRIN; PRAVASTATIN SODIUM
`
`TABLET, TABLET
`
`ASPIRIN; PRAVASTATIN SODIUM
`
`TABLET, TABLET
`
`ASPIRIN; PRAVASTATIN SODIUM
`
`TABLET, TABLET
`
`N200671
`
`DURLAZA
`
`ASPIRIN
`
`N203697
`
`ASPIRIN
`
`ASPIRIN
`
`CAPSULE,
`EXTENDED
`RELEASE
`
`CAPSULE
`
`Reference ID: 3985744
`
`

`

`Attachment for Part II Question #2
`
`
`
`
`N019810
`
`
`PRILOSEC
`
`
`OMEPRAZOLE
`
`N019810
`
`PRILOSEC
`
`OMEPRAZOLE
`
`N019810
`
`PRILOSEC
`
`OMEPRAZOLE
`
`N021229
`
`PRILOSEC OTC
`
`OMEPRAZOLE MAGNESIUM
`
`N021636
`
`ZEGERID
`
`N021636
`
`ZEGERID
`
`N021849
`
`ZEGERID
`
`N021849
`
`ZEGERID
`
`N021850
`
`ZEGERID
`
`N021850
`
`ZEGERID
`
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`MAGNESIUM HYDROXIDE;
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`MAGNESIUM HYDROXIDE;
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`N022032
`
`OMEPRAZOLE
`
`OMEPRAZOLE
`
`N022056
`
`PRILOSEC
`
`OMEPRAZOLE MAGNESIUM
`
`N022056
`
`PRILOSEC
`
`OMEPRAZOLE MAGNESIUM
`
`N022281
`
`ZEGERID OTC
`
`N022283
`
`ZEGERID OTC
`
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`
`CAPSULE, DELAYED
`REL PELLETS
`
`CAPSULE, DELAYED
`REL PELLETS
`
`CAPSULE, DELAYED
`REL PELLETS
`
`TABLET, DELAYED
`RELEASE
`
`FOR SUSPENSION
`
`FOR SUSPENSION
`
`CAPSULE
`
`CAPSULE
`
`TABLET, CHEWABLE
`
`TABLET, CHEWABLE
`
`TABLET, DELAYED
`RELEASE
`
`FOR SUSPENSION,
`DELAYED RELEASE
`
`FOR SUSPENSION,
`DELAYED RELEASE
`
`CAPSULE
`
`FOR SUSPENSION
`
`N022456
`
`MAGNESIUM
`HYDROXIDE AND
`
`MAGNESIUM HYDROXIDE;
`OMEPRAZOLE; SODIUM
`
`TABLET
`
`Reference ID: 3985744
`
`

`

`Attachment for Part II Question #2
`
`OMEPRAZOLE AND
`SODIUM
`BICARBONATE
`
`MAGNESIUM
`HYDROXIDE AND
`OMEPRAZOLE AND
`SODIUM
`BICARBONATE
`
`OMEPRAZOLE AND
`CLARITHROMYCIN
`AND AMOXICILLIN
`
`BICARBONATE
`
`MAGNESIUM HYDROXIDE;
`OMEPRAZOLE; SODIUM
`BICARBONATE
`
`TABLET
`
`AMOXICILLIN;
`CLARITHROMYCIN; OMEPRAZOLE
`
`CAPSULE,TABLET,
`CAPSULE, DELAYED
`RELEASE
`
`
`
`N022456
`
`N050824
`
`
`
`Reference ID: 3985744
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MIMI T PHAN
`09/14/2016
`
`DONNA J GRIEBEL
`09/14/2016
`
`Reference ID: 3985744
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`EXCLUSIVITY SUMMARY
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`NDA # 205103
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`SUPPL # N/A
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`HFD # 180
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`Trade Name Yosprala
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`Generic Name aspirin/omeprazole
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`Applicant Name Pozen, Inc.
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`Approval Date, If Known April 25, 2014
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`PART I
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
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`1. An exclusivity determination will be made for all original applications, and all efficacy
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`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
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`one or more of the following questions about the submission.
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`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
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`YES g
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`NO [1
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`Ifyes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
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`505(b)(2)
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`c) Did it require the review of clinical data other than to support a safety claim or change in
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`labeling related to safety? (If it required review only of bioavailability or bioequivalence
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`data, answer "no.")
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`YES X
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`NO D
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`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
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`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
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`reasons for disagreeing with any arguments made by the applicant that the study was not
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`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
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`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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`YES IZI
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`NO [:1
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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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`e) Has pediatric exclusivity been granted for this Active Moiety?
`YES [I
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`NO X
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`If the answer 19 the gbgyg question in 1 ES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
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`No
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
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`2. Is this drug product or indication a DESI upgrade?
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`YESE]
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`NoXl
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`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
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`PART II
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`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
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`(Answer either #1 or #2 as appropriate)
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`1. Single active ingredient product.
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`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form 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.
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`YES El
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`NO E]
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`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
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`Page 2
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`019810, 022056
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`OTC: 021229
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`n/a
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`Omeprazole (Prilosec)
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`EC Aspirin 81mg, 325mg
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`NDA#
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`NDA#
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`NDA#
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`2. Combination product.
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`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
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`approved an application under section 505 containing m E of the active moieties in the drug
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`product? If, for example, the combination contains one never-before—approved active moiety and
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`one previously approved active moiety, answer "yes. " (An active moiety that is marketed under an
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`OTC monograph, but that was never approved under an NDA,
`is considered not previously
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`d.
`approve )
`YES
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`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
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`#(s).
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`NDA# 019810, 022056
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`OTC: 021229
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`NDA#
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`NDA# n/a
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`Omeprazole Prilosec
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`EC ASA 81mg, 325mg
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`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART 11 IS "NO," GO DIRECTLY TO THE
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`SIGNATURE BLOCKS ON PAGE 8.
`(Caution: The questions in part II of the summary should
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`only be answered “NO” for original approvals of new molecular entities.)
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`IF “YES,” GO TO PART HI.
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`PART III
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
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`To qualify for three years of exclusivity, an application or supplement must contain ”reports of new
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`clinical investigations (other than bioavailability studies) essential to the approval of the application
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`and conducted or sponsored by the applicant." This section should be completed only if the answer
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`to PART 11, Question 1 or 2 was "yes."
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`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
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`Page 3
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`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
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`the application contains clinical investigations only by virtue of a right of reference to clinical
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`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
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`is "yes" for any investigation referred to in another application, do not complete remainder of
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`summary for that investigation.
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`YES
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`NO (:1
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`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
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`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
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`application or supplement without relying on that investigation. Thus, the investigation is not
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`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
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`application in light of previously approved applications (i.e., information other than clinical trials,
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`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
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`505(b)(2) application because ofwhat is already known about a previously approved product), or 2)
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`there are published reports of studies (other than those conducted or sponsored by the applicant) or
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`other publicly available data that independently would have been sufficient to support approval of
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`the application, without reference to the clinical investigation submitted in the application.
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`(a) In light of previously approved applications, is a clinical investigation (either conducted
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`by the applicant or available from some other source, including the published literature)
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`necessary to support approval of the application or supplement?
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`YES E
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`NO [I
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`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
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`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
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`(b) Did the applicant submit a list of published studies relevant to the safety and effectiveness
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`of this drug product and a statement that the publicly available data would not independently
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`support approval of the application?
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`YES |:|
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`NO
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`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
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`with the applicant's conclusion? If not applicable, answer NO.
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`YES D
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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
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`sponsored by the applicant or other publicly available data that could independently
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`demonstrate the safety and effectiveness of this drug product?
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`YES D
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`NO g
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`If yes, explain:
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`(c)
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`Ifthe answers to (b)(l) and (b)(2) were both "no," identify the clinical investigations
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`submitted in the application that are essential to the approval:
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`The approval was based on the results of the clinical trials that were
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`submitted in the application 1) Study PA32540-301 and 2) Study PA32540-302
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`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
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`studies for the purpose of this section.
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`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
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`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
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`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
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`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
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`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
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`agency considers to have been demonstrated in an already approved application.
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`a) For each investigation identified as "essential to the approval," has the investigation been
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`relied on by the agency to demonstrate the effectiveness of a previously approved drug
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`product?
`(If the investigation was relied on only to support the safety of a previously
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`approved drug, answer "no.")
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`Investigation #IStudy PA32540-301
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`Investigation #2 Study PA32540-302
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`YES I]
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`NO
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`NO E
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`If you have answered "yes" for one or more investigations, identify each such investigation
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`and the NDA in which each was relied upon:
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`b) For each investigation identified as "essential to the approval", does the investigation
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`duplicate the results of another investigation that was relied on by the agency to support the
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`effectiveness of a previously approved drug product?
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`Page 5
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`Investigation #1 Study PA32540-301
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`Investigation #2 Study PA32540-302
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`YES [I
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`NO g
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`NO IX]
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`If you have answered "yes" for one or more investigation, identify the NDA in which a
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`similar investigation was relied on:
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`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
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`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
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`that are not "new"):
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`Study PA32540—301 and Study PA32540-302
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`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
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`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
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`the applicant if, before or during the conduct ofthe investigation, 1) the applicant was the sponsor of
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`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
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`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
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`providing 50 percent or more of the cost of the study.
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`a) For each investigation identified in response to question 3(c): if the investigation was
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`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
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`Investigation #1
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`IND # 78747
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`YES X
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`NOE]
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`Explain:
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`Investigation #2
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`IND # 78747
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`YES
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`NOD
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`Explain:
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`Page 6
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`(b) For each investigation not carried out under an IND or for which the applicant was not
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`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
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`interest provided substantial support for the study?
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`N/A
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`NOE!
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`Explain:
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`NOD
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`Explain:
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`! ! !
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`!
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`1“.—.—.——
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`Investigation #1
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`YES El
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`Explain:
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`Investigation #2
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`YES |:]
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`Explain:
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`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
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`the applicant should not be credited with having "conducted or Sponsored" the study?
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`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
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`drug are purchased (not just studies on the drug), the applicant may be considered to have
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`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
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`YES D
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`NO E
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`If yes, explain:
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`11
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`Name of person completing form: Stacy Barley
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`Title: Senior Regulatory Project Manager
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`Date:
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`Name of Office/Division Director Signing form: Donna Griebel
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`Title: Director
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`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12
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`Page 7
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`Transforming medicine. Transforming lives.
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`1414 Raleigh Road I Suite 400 l Chapel Hill. NC 27517
`Phone: 919.913.1030 | Fax: 919.913.1039
`www.pozen.co m
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`NDA # 205103
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`PA8140 and PA32540 (aspirin 81 mg or 325 mg/omeprazole 40 mg) Tablets
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`MODULE 1.3.3
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`DEBARMENT CERTIFICATION
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`POZEN Inc. h