CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208194Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`
`

`

`EXCLUSIVITY SUMMARY
`
`
`NDA # 208194
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`SUPPL # N/A
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`HFD # 161
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
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`Trade Name Bendeka granted on 6/16/15
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`Generic Name bendamustine hydrochloride
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`Applicant Name Eagle Pharmaceuticals, Inc.
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`Approval Date, If Known December 7, 2015
`
`PART I
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`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
`
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`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
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` YES
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`NO
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`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`
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`505(b)(2)
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`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.")
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` YES
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`NO
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`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
`The primary study EGL-BDM-C-1301 is a bioequivalence study. For the purposes of
`qualifying for exclusivity, a BE study is not considered a clinical study.
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`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data: N/A
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`Reference ID: 3856826
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`Page 1
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`c) Did the applicant request exclusivity?
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` YES
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`NO
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`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
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`The listed drug Treanda has Pediatric Exclusivity that expires on
`requests both
` of exclusivity.
`
`. Eagle
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`d) Has pediatric exclusivity been granted for this Active Moiety?
`
`
` YES
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`
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`NO
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`No
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`If the answer to the above question is YES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
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`
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
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`2. Is this drug product or indication a DESI upgrade?
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` YES
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`NO
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`Reference ID: 3856826
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`Page 2
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`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
`
`
`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen or
`coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has
`not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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` YES
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`NO
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`(b) (4)
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`(b) (4)
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`

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`NDA# 022249
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`NDA#
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`NDA#
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`Treanda
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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`NDA#
`NDA#
`NDA#
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`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`
`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
`
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`2. Combination product.
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`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing any one of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
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`YES
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`NO
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
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`Reference ID: 3856826
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`Page 3
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`

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`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
`is "yes" for any investigation referred to in another application, do not complete remainder of
`summary for that investigation.
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`
`
`NO
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`
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`YES
`
`
`The primary study EGL-BDM-C-1301 is a bioequivalence study.
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`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
`
`(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:
`
`
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`NO
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`(b) Did the applicant submit a list of published studies relevant to the safety and effectiveness
`of this drug product and a statement that the publicly available data would not independently
`support approval of the application?
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`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
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` YES
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`NO
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` If yes, explain:
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` YES
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`NO
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`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
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`
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`Reference ID: 3856826
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`Page 4
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` If yes, explain:
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` YES
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`NO
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`(c)
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`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`
`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.
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`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
`
`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`
`
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`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
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`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
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`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`Reference ID: 3856826
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`Page 5
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`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
`
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
`the applicant if, before or during the conduct of the investigation, 1) the applicant was the sponsor of
`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
`providing 50 percent or more of the cost of the study.
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`Investigation #1
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`YES
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`Investigation #2
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`a) For each investigation identified in response to question 3(c): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`!
`!
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`! NO
`! Explain:
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`!
`!
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`YES
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`! NO
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`! Explain:
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`IND #
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`(b) For each investigation not carried out under an IND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
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`Investigation #1
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`YES
`Explain:
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`!
`!
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`! NO
`! Explain:
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`Reference ID: 3856826
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`Page 6
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`Investigation #2
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`YES
`Explain:
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`!
`!
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`! NO
`! Explain:
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`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
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`YES
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`NO
`
`
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`If yes, explain:
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`
`=================================================================
`
`Name of person completing form: Laura Wall, MS
`Title: Regulatory Project Manager
`Date: December 7, 2015
`
`
`Name of Office/Division Director signing form: Ann T. Farrell, MD (Edvardas Kaminskas, MD
`signed this form on behalf of Ann T. Farrell)
`Title: Director/Division of Hematology Products
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`
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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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`Reference ID: 3856826
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`Page 7
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LAURA C WALL
`12/07/2015
`
`EDVARDAS KAMINSKAS
`12/07/2015
`
`Reference ID: 3856826
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`

`

`PEDIATRIC PAGE
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`(Complete for all filed original applications and efficacy supplements)
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`NDA/BLA#: 208194
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`-
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`Supplement Number: [MA
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`NDA Supplement Type (e.g. SE5):
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`Division Name:Division of
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`Hematology Products
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`PDUFA Goal Date:
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`12/13/2015
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`Proprietary Name:
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`Bendeka granted on 6/16/15
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`Established/Generic Name: bendamustine hydrochloride
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`Dosage Form:
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`lniection
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`Applicant/Sponsor:
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`Eagle Pharmaceuticals, Inc.
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`Stamp Date: 2/13/2015
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`|ndication(s)W (please complete this question for supplements and Type 6 NDAs only):
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`(1)
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`(2) __
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`(3) _
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`(4)
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`Pediatric use for each pediatric subpopulation must be addressed for each indication covered by current
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`application under review. A Pediatric Page must be completed for each indication.
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`Number of indications for this pending application(s):g
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`(Attach a completed Pediatric Page for each indication in current application.)
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`Indication: Indolent Non-Hodgkin Lymphoma
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`Q1: Is this application in response to a PREA PMR?
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`Yes I:| Continue
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`No E Please proceed to Question 2.
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`PMR #:___
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`Supplement #:
`If Yes, NDA/BLA#:
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`Does the division agree that this is a complete response to the PMR?
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`1:] Yes. Please proceed to Section D:
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`I:] No. Please proceed to Question 2 and complete the Pediatric Page, as applicable.
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`Q2: Does this application provide for (If yes, please check all categories that apply and proceed to the next
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`question):
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`(a) NEW I:I active ingredient(s) (includes new combination); I] indication(s); D dosage form; fl dosing
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`regimen; or I:I route of administration?*
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`(b) [I No. PREA does not apply. Skip to signature block.
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`* Note for CDER: SE5, SE6, and SE7 submissions may also trigger PREA.
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`Q3: Does this indication have orphan designation?
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`E Yes. PREA does not apply. Skip to signature block.
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`D No. Please proceed to the next question.
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`Q4: Is there a full waiver for all pediatric age groups for this indication (check one)?
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`[:1 Yes: (Complete Section A.)
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`[:1 No: Please check all that apply:
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`1:] Partial Waiver for selected pediatric subpopulations (Complete Sections B)
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`[:l Deferred for some or all pediatric subpopulations (Complete Sections C)
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`|:| Completed for some or all pediatric subpopulations (Complete Sections D)
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`D Appropriately Labeled for some or all pediatric subpopulations (CompletevSections E)
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`D Extrapolation in One or More Pediatric Age Groups (Complete Section F)
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`ReferefiggugggagggmUESTmNs, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cderpmhs@fda.hhs.gov) 0R AT 301-796-0700.
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`

`

`NDA/BLA# 208194208194208194208194208194
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`Page 2
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`Please note that Section F ma be used alone or in addition to Sections C, D, and/or E.
` Section A: Fully Waived Studies (for all pediatric age groups)
`
`Reason(s) for full waiver: (check, and attach a brief justification for the reason(s) selected)
`
`E] Necessary studies would be impossible or highly impracticable because:
`[I Disease/condition does not exist in children
`
`I] Too few children with disease/condition to study
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`El Other (e.g., patients geographically dispersed): _
`
`E] Product does not represent a meaningful therapeutic benefit over existing therapies for pediatric
`patients AND is not likely to be used in a substantial number of pediatric patients.
`[:1 Evidence strongly suggests that product would be unsafe in all pediatric subpopulations (Note: if
`studies are fully waived on this ground, this information must be included in the labeling.)
`
`[3 Evidence strongly suggests that product would be ineffective in all pediatric subpopulations (Note: if
`studies are fully waived on this ground, this information must be included in the labeling.)
`D Evidence strongly suggests that product would be ineffective and unsafe in all pediatric
`subpopulations (Note: if studies are fully waived on this ground, this information must be included in
`the labeling.)
`|:| Justification attached.
`
`If there is another
`If studies are fully waived, then pediatric information is complete for this indication.
`indication, please complete another Pediatric Page for each indication. Othemise, this Pediatric Page is
`complete and should be signed.
`
`Section B: Partially Waived Studies (for selected pediatric subpopulations)
`
`Check subpopulation(s) and reason for which studies are being partially waived (fill in applicable criteria below):
`
`Note: If Neonate includes premature infants, list minimum and maximum age in "gestational age” (in weeks).
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`
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`Reason (see below for further detail):
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`Not meaningful
`therapeutic
`benefit*
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`Ineffective or
`Formulation
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`m
`
`inimum
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`maximum
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`NOt
`feasible”
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`“mm-:-
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`
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`Are the indicated age ranges (above) based on weight (kg)?
`Are the indicated age ranges (above) based on Tanner Stage?
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`D No; C] Yes.
`I] No; [I Yes.
`
`Reason(s) for partial waiver (check reason corresponding to the category checked above, and attach a brief
`justification):
`# Not feasible:
`
`I] Necessary studies would be impossible or highly impracticable because:
`[I
`Disease/condition does not exist in children
`
`1:]
`[:1
`
`Too few children with disease/condition to study
`Other (e.g., patients geographically dispersed): _
`
`* Not meaningful therapeutic benefit:
`E] Product does not represent a meaningful therapeutic benefit over existing therapies for pediatric
`patients in this/these pediatric subpopulation(s) AND is not likely to be used in a substantial number of
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` crnmhs‘fi‘ f'daJIhs. in) OR AT 301-796-0700.
`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL cc
`Reference ID: 3853678
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`

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`NDA/BLA# 208194208194208194208194208194
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`Page 3
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`pediatric patients in this/these pediatric subpopulation(s).
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`1- lneffective or unsafe:
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`El Evidence strongly suggests that product would be unsafe in all pediatric subpopulations (Note: if studies
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`I:| Evidence strongly suggests that product would be ineffective in all pediatric subpopulations (Note: if
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`studies are partially waived on this ground, this information must be included in the labeling.)
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`I:I Evidence strongly suggests that product would be ineffective and unsafe in all pediatric subpopulations
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`(Note: if studies are partially waived on this ground, this information must be included in the labeling.)
`A Formulation failed:
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`[1 Applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for
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`this/these pediatric subpopulation(s) have failed. (Note: A partial waiver on this ground may mix cover
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`the pediatric subpopulation(s) requiring that formulation. An applicant seeking a partial waiver on this
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`ground must submit documentation detailing why a pediatric formulation cannot be developed. This
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`submission will be posted on FDA '3 website if waiver is granted.)
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`D Justification attached.
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`For those pediatric subpopulations for which studies have not been waived, there must be ( 1) corresponding
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`study plans that have been deferred (if so, proceed to Sections C and complete the PeRC Pediatric Plan
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`Template); (2) submitted studies that have been completed (if so, proceed to Section D and complete the
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`PeRC Pediatric Assessment form); (3) additional studies in other age groups that are not needed because the
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`drug is appropriately labeled in one or more pediatric subpopulations (if so, proceed to Section E); and/or (4)
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`additional studies in other age groups that are not needed because efficacy is being extrapolated (if so,
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`proceed to Section F). Note that more than one of these options may apply for this indication to cover a_ll of the
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` Section C: Deferred Studies (for selected pediatric subpopulations).
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`Check pediatric subpopulation(s) for which pediatric studies are being deferred (and fill in applicable reason
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`Deferrals (for each or all age groups):
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`Applicant
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`Date studies are due((:mm/dd/yy) __
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`Are the indicated age ranges (above) based on weight (kg)?
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`1:] No; [I Yes.
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`Are the indicated age ranges (above) based on Tanner Stage? D No; I] Yes.
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`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cdernmhsmdahhs.gov) OR AT 301-796-0700.
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`Reference ID: 3853678
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`NDA/BLA# 208194208194208194208194208194
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`Page 4
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`* Other Reason:
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`1' Note: Studies may only be deferred if an applicant submits a certification of grounds for deferring the studies,
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`a description of the planned or ongoing studies, evidence that the studies are being conducted or will be
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`conducted with due diligence and at the earliest possible time, and a timeline for the completion of the studies.
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`If studies are deferred, on an annual basis applicant must submit information detailing the progress made in
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`conducting the studies or, if no progress has been made, evidence and documentation that such studies will be
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`conducted with due diligence and at the earliest possible time. This requirement should be communicated to
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`the applicant in an appropriate manner (e.g., in an approval letter that specifies a required study as a post-
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`If all of the pediatric subpopulations have been covered through partial waivers and deferrals, Pediatric Page is
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`complete and should be signed.
`If not, complete the rest of the Pediatric Page as applicable.
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` Section D: Completed Studies (for some or all pediatric subpopulations).
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`Pediatric subpopulation(s) in which studies have been completed (check below):
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`PeRC Pediatric Assessment form
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`attached?.
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`Neonate
`wk.
`_ wk. _ mo.
`mo.
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`_,.. _mo.
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`16 yr. 11 mo.
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`vesm
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`Yes [I
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`Are the indicated age ranges (above) based on weight (kg)?
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`Are the indicated age ranges (above) based on Tanner Stage?
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`|:| No; |:I Yes.
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`I:I No; [:1 Yes.
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`Note: If there are no further pediatric subpopulations to cover based on partial waivers, deferrals and/or
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`completed studies, Pediatric Page is complete and should be signed.
`If not, complete the rest of the Pediatric
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`Page as applicable.
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`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cderpmhs@fd2.hhs.gov) OR AT 301-796-0700.
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`Reference ID: 3853678
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`

`

`NDA/BLA# 208194208194208194208194208194
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`Section E: Drug Appropriately Labeled (for some or all pediatric subpopulations):
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`Page 5
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`Additional pediatric studies are not necessary in the following pediatric subpopulation(s) because product is
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`appropriately labeled for the indication being reviewed:
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`Neonate
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`minimum
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`maxrmum
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`Are the indicated age ranges (above) based on weight (kg)?
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`l:l No; I:I Yes.
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`Are the indicated age ranges (above) based on Tanner Stage?
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`If all pediatric subpopulations have been covered based on partial waivers, deferrals, completed studies, and/or
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`existing appropriate labeling, this Pediatric Page is complete and should be signed.
`If not, complete the rest of
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`the Pediatric Page as applicable.
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`I: No; El Yes.
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` Section F: Extrapolation from Other Adult and/or Pediatric Studies (for deferred and/or completed studies)
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`Note: Pediatric efficacy can be extrapolated from adequate and well-controlled studies in adults and/or other
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`pediatric subpopulations if (and only in (1) the course of the disease/condition M (2) the effects of the
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`product are sufficiently similar between the reference population and the pediatric subpopulation for which
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`information will be extrapolated. Extrapolation of efficacy from studies in adults and/or other children usually
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`requires supplementation with other information obtained from the target pediatric subpopulation, such as
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`pharmacokinetic and safety studies. Under the statute, safety cannot be extrapolated.
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`Pediatric studies are not necessary in the following pediatric subpopulation(s) because efficacy can be
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`extrapolated from adequate and well-controlled studies in adults and/or other pediatric subpopulations:
`Extrapolated from:
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`Other Pediatric
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`Studies?
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` _wk-_mo- D
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`Population
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`minimum
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`maximum
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`Adult Studies?
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`Other
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`I:_——
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`All Pediatric
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`Subpopulations
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`0 yr. 0 mo.
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`Are the indicated age ranges (above) based on weight (kg)?
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`Are the indicated age ranges (above) based on Tanner Stage?
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`Note: If extrapolating data from either adult or pediatric studies, a description of the scientific data supporting
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`the extrapolation must be included in any pertinent reviews for the application.
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`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cderpmhsga)fda.hhs.gov) OR AT 301-796-0700.
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`Reference ID: 3853678
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`D No; [:1 Yes.
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`I:I No; I:| Yes.
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`NDA/BLA# 208194208194208194208194208194
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`Page 6
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`If there are additional indications, please complete the attachment for each one of those indications.
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`Otherwise, this Pediatric Page is complete and should be signed and entered into DFS or DARRTS as
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`appropriate afler clearance by PeRC.
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`This page was completed by:
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`{See appended electronic signature page}
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`Regulatory Project Manager
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`(Revised: 6/2008)
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`NOTE:
`If you have no other indications for this application, you may delete the attachments from this
`document.
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`IF THERE ARE QUESTIONS, PLEASE CONTACT THE CDER PMHS VIA EMAIL (cdernmhsfibfdahhsgov) 0R AT 301-796-0700.
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`Reference ID: 3853678
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`

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`NDA/BLA# 208194208194208194208194208194
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`Page 7
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`Attachment A
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`(This attachment is to be completed for those applications with multiple indications only.)
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`Indication #2: chronic lymphocflic leukemia (CLL)
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`Q1: Does this indication have orphan designation?
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`El Yes. PREA does not apply. Skip to signature block.
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`[I No. Please proceed to the next question.
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`02: Is there a full waiver for all pediatric age groups for this indication (check one)?
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`I: Yes: (Complete Section A.)
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`E] No: Please check all that apply:
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`I:l Partial Waiver for selected pediatric subpopulations (Complete Sections B)
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`E] Deferred for some or all pediatric subpopulations (Complete Sections C)
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`El Completed for some or all pediatric subpopulations (Complete Sections D)
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`I:I Appropriately Labeled for some or all pediatric subpopulations (Complete Sections E)
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`I:| Extrapolation in One or More Pediatric Age Groups (Complete Section F)
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`(Please note that Section F may be used alone or in addition to Sections C, D, and/or E.)
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`Section A: Fully Waived Studies (for all pediatric age groups)
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`Reason(s) for full waiver: (check, and attach a briefjustification for the reason(s) selected)
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`I] Necessary studies would be impossible or highly impracticable because:
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`El Disease/condition does not exist in children
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`I] Too few children with disease/condition to study
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