CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICATION NUMBER: 020717
`
`ADMINISTRATIVE/CORRESPONDENCE DOCUMENTS
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`Public Health Service
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`\_\\_
`Food and Drug Administration
`Rockvillc MD 20857
`
`NDA 20-717
`
`Cephalon, lnc.
`Attention: Paul Nemeth, Ph.D.
`145 Brandywine Parkway
`West Chester, PA 19380-4245
`0
`
`Dear Dr. Nemeth:
`
`Please refer to your new drug application dated December 27, 1996, received
`December 30, 1996, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act for Provigil® (modafinil) Tablets.
`
`We acknoWledge receipt of your additional correspondences and amendments dated:
`
`February 14, 1997
`March 27, 1997
`March 31, 1997
`April 8, 1997
`April 9, 1997
`April 10, 1997
`April 11, 1997
`April 18, 1997
`May 1, 1997
`May 2, 1997
`
`May 5, 1997
`May 12, 1997
`June 2, 1997
`June 3, 1997
`June 12, 1997
`June 16, 1997
`June 17, 1997
`June 23, 1997
`July 3, 1997
`July 8, 1997
`
`September 22, 1997
`July 17, 1997
`September 26, 1997
`July 28, 1997
`October 7, 1997
`July 30, 1997
`October 9, 1997
`July 31, 1997
`October 20, 1997
`August 18, 1997
`September 2, 1997 November 5, 1997
`September 5, 1997 November 11, 1997
`September 9, 1997 November 14. 1997
`September 15, 1997
`September 19, 1997
`
`‘ We have completed the review of this application as submitted with draft labeling, and it
`is approvable. Before this application may be approved, however, it will be necessary for
`you to respond to the following requests or comments.
`
`Labefinglssues
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`have embedded throughout the text of the
`requesting further revisions or clarification of th
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`1. Dosageand Administration Section
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`NDA 20-717
`Page 3
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`4. Safety Update
`
`Under 21 CFR 314.50(d)(5)(vi)(b), we request that you update your NDA by submitting
`all safety information you now have regarding your new drug. Please provide updated
`information as listed below:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Retabulate all safety data including results of trials that were still ongoing
`at the time of NDA submission. The tabulation can take the same form as
`in your initial submission. Tables comparing adverse reactions at the time
`the NDA was submitted 15 now will certainly facilitate review.
`
`Retabulate drop-outs with new drop~outs identified. Discuss, if
`appropriate.
`
`Provide details of any significant changes or findings, if any.
`
`Summarize worldwide experience on the safety of this drug.
`
`Submit case report forms for each patient who died during a clinical study
`or who did not complete a study because of an adverse event.
`
`Pharmacology
`
` .
`
`
`
`2. Your reproductive toxicology package is inadequate for evaluation of the full
`spectrum of potential effects of Provigil on fertility or on the fetus. With the exception of
`a peri- and post-natal study, which was conducted in 1995. the reproductive toxicology
`studies were not conducted in compliance with Good Laboratory Practices (GLP)
`regulations and their value for predicting potentil toxicity is marginal.
`In addition, the
`fertility and teratology studies were carried out at doses which were too low to obtain
`appropriate exposures (ICH Guideline for industry “Detection of Toxicity to
`Reproduction for Medicinal Products”, page A-4, Selection of Dosages). The high dose
`used in the rat teratology study was associated with some minimal fetal toxicity, and the
`potential magnitude of fetal effects should be better characterized given that the patient
`population for which Provigil is indicated includes women of child-bearing potential.
`
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`Page 4
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` .
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`
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`Biopharmaceutics
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`I
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`1. Please submit for our review information regarding the interconversion of
`enantiomers.
`
`(I: i.
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`-_
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`substrates).
`
`4. We ask that the following final dissolution methodology and specification be adopted
`for Provigil® Tablets (100mg and 200mg):
` .
`
`
`
`Chemistry, Manufacturing, and Controls
`
` .
`
` .
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`1.
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`Scheduling
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`A final decision regarding the appropriate schedule into which Provigil® Tablets will be
`classified has not been made.
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`A
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`Page 5
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`Promotional Material
`
`propose to use for this product. All proposed materials should be submitted in draft or
`
`Food and Drug Administration
`Division of Drug Marketing, Advertising and Communications,
`HFD-40
`
`5600 Fishers Lane
`Rockville, Maryland 20857
`
`Vlfithin 10 days after the date of this letter, you are required to amend the application,
`notify us of your intent to file an amendment, or follow one of your other options under
`21 CFR 314.110.
`In the absence of Such action FDA may take action to withdraw the
`application.
`
`If additional information relating to the safety or effectiveness of this drug becomes
`available, revision of the labeling may be required.
`
`The drug may not be legally marketed until you have been notified in writing that the
`application is approved.
`
`If you have any questions, please contact Melina Malandrucco, R.Ph., Regulatory
`Management Officer, at (301) 594-5526.
`
`Sincerely yours,
`
`/S/
`/S/
`
`Robert Temple, MD.
`Director
`
`Office of Drug Evaluation l
`Center for Drug Evaluation and Research
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`20-717
`NDA:
`Provigil
`Trade Name:
`modafinil
`Generic Name:
`Cephalon
`Applicant Name:
`‘
`HFD-120
`Division:
`Project Manager: Melina Malandrucco, R.Ph.
`Approval Date:
`
`u
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`“ P
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`ART I
`
`WWWDED?
`
`1. An exclusivity determination will be made for all original applications, but only for certain
`supplements. Complete Parts 11 and III ofthis Exclusivity Summary only ifyou answer "yes"
`to one or more of the following questions about the submission.
`
`a.
`b.
`
`Is it an original NBA?
`Is it an effectiveness supplement?
`If yes, what type? (SE1, SE2, etc.)
`
`993%
`No
`
`c. Did it require the review ofclinical data other than to support a safety claim or Yes
`change in labeling related to safety?
`(If it required review only of
`bioavailability or bioequivalence data, answer "no. ")
`
`Ifyour answer is "no" because you believe the studyis a bioavailability study N/A
`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 N/A
`efiecn'veness supplement, describe the change or claim that is supported by the
`clinical data:
`
`Egg
`d. Did the applicant request exclusivity?
`Ifthe answer "yes," how many years of exclusivity did the applicant request? Eyrs!
`Kym...
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE
`QUESTIONS, GO DIRECTLY TO THE SIGNATURE BLOCKS.
`
`2. Has a product with the same active ingredient(s), dosage form, strength, route of No
`administration, and dosing schedule previously been approved by FDA for the same "
`use?
`
`If yes, what is NDA number
`
`If yes, what is Drug Name
`
`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE
`SIGNATURE BLOCKS.
`
`3.
`
`Is this drug product or indication a DESI upgrade?
`
`No
`
`IF THE ANSWER TO QUESTION 3 IS "YES," GO DIRECTLY TO THE
`SIGNATURE BLOCKS (even if a study was required for the upgrade).
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`>
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`mm
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`0M5;
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`{tau—NJ Q9: '
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`PART 1]
`
`N9
`
`l.
`
`WWW
`(Answer either #1 or #2, as appropriate)
`Wham
`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"
`ifthe 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).
`
`Llthinatimeruct.
`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.)
`
`mg;
`
`If "yes," identify the approved drug product(s) containing the active moiety, and,
`if known, the NDA #(s).
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART 11 IS "NO," GO
`DIRECTLY TO THE SIGNATURE BLOCKS. IF "YES," GO TO PART
`III.
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`PART III
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`WWWm
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`To qualify for three years ofexclusivity, an application or supplement must contain "reports ofnew
`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 II, Question 1 or 2, was "yes."
`
`(The Agency
`1. Does the application contain reports of clinical investigations?
`interprets "clinical investigations" to mean investigations conducted on humans
`other than bioavailability studies.) Ifthe application contains clinical investigations
`only by virtue ofa right ofreference 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.
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS.
`
`2. A clinical investigation is "essential to the approval" ifthe 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 ofstudies (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.
`
`For the purposes of this section, studies comparing two products with the same
`ingredient(s) are considered to be bioavailability studies.
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`(v
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`a.
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`In light ofpreviously approved applications, is aclinical investigation (either
`
`conducted by the applicant or available fi-om some other source, including the
`published literature) necessary to support approval of the application or
`supplement?
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary
`for approval AND GO DIRECTLY TO SIGNATURE BLOCKS.
`
`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?
`
`Ifthe 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.
`
`1)
`
`2)
`
`If yes, explain:
`
`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 efi‘ectiveness of this
`drug product?
`
`If yes, explain:
`
`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:
`
`’
`
`Investigation #1, Study #2
`
`Investigation #2, Study #:
`
`Investigation #3, Study #:
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`-
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`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 ofa 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.
`
`to the approval," has the
`a For each investigation identified as "essential
`investigation been relied on by the agency to demonstrate the effectiveness of
`a previously approved drug product? (Ifthe investigation was relied on only to
`support the safety of a previously approved drug, answer "no.")
`
`Investigation #1
`
`Investigation #2
`
`Investigation #3
`
`If you have answered "yes" for one or more investigations, identify each such
`investigation and the NDA in which each was relied upon:
`
`NDA:
`
`NDA:
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`NDA:
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`x.
`
`Study:
`
`Study:
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`Study:
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`b.
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`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?
`
`' m
`
`Investigation #1
`
`Investigation #2
`
`Investigation #3
`
`If you have answered "yes" for one or more investigations, identify the NDA
`in which a similar investigation was relied on:
`
`NDA:
`
`NDA:
`
`Study:
`
`Study:
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`NDA:
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`Study:
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`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"):
`
`Investigation #:
`
`Investigation #:
`
`Study #:
`
`Study #2
`
`4.
`
`Study #:
`Investigation #:
`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 ofthe 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): ifthe
`investigation was carried out under an IND, was the applicant identified on
`the FDA 1571 as the sponsor?
`
`.
`
`Investigation #1
`
`IND#:
`
`Investigation #2
`
`IND#:
`
`Investigation #2
`
`IND#:
`
`Explain:
`
`Explain:
`
`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
`
`Explain:
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`Investigation #2
`
`Explain:
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`C
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`Investigation #3
`
`Explain:
`
`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.)
`
`If yes, explain:
`
`/S/
`
`
`
`Melina Malandrucco, R.Ph.
`Project Manager
`DNDP, HFD-IZO
`
`K CC:
`
`Original NDA
`
`Division File
`
`HFD-IZO/ Malandrucco
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`HFD'SS/HOIOV APPEARS THIS WAY ON ORIGINAL
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`Paul Leber, M.D.
`Director
`DNDP, HFD-120
`
`
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`DRUG STUDIES IN PEDIATRIC PATIENTS
`(To be completed for all NME's recommended for approval)
`
`NDA # 29112
`
`Trade (generic) names Emigilmgdaflnm
`
`Check any of the following that apply and explain, as necessary, on the next page:
`
`1.
`
`2.
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`3.
`
`6
`~ "
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`
`
`C
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`.._
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`‘
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`A proposed claim in the draft labeling is directed toward a specific pediatric
`illness. The application contains adequate and well-controlled studies in
`pediatric patients to support that claim.
`
`The draft labeling includes pediatric dosing information that is not based on
`adequate and well-controlled studies in children. The application contains a
`request under 21 CFR 210.58 or 314.126(c) for waiver of the requirement at
`21 CFR 201 .57(f) for A&WC studies in children.
`
`———.
`
`a.
`
`The application contains data showing that the course of the
`disease and the effects of the drug are sufficiently similar in
`adults and children to permit extrapolation of the data from
`adults to children. The waiver request should be granted and a
`statement to that effect is included in the action letter.
`
`b.
`
`The information included in the application does not
`adequately support the waiver request. The request should not
`be granted and a statement to that effect is included in the
`action letter. (Complete #3 and #4 below as appropriate.)
`
`Pediatric studies (e.g., dose-finding, pharmacokinetic, adverse reaction,
`adequate and well-controlled for safety and efficacy) should be done after
`approval. The drug product has some potential for use in children, but there
`is no reason to expect early widespread pediatric use (because, for example,
`alternative drugs are available or the condition is uncommon in children).
`—_.......
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`a.
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`The applicant has committed to doing such studies as will be
`required.
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`n“...
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`h...-
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`—__.__
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`(1)
`(2)
`(3)
`(4)
`
`Studies are ongoing.
`Protocols have been submitted and approved.
`Protocols have been submitted and are under
`review.
`If no protocol has been submitted, on the next
`page explain the status of discussions.
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`b.
`If the sponsor is not willing to do pediatric studies, attach
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`Drug Studies i n Pediatric Patients
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`2
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`copies of FDA's written request that such studies be done and
`of the sponsor's written response to that request.
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`_L_ 4.
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`Pediatric studies do not need to be encouraged because the drug product has
`little potential for use in children.
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`- E
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`5.
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`If none of the above apply, explain.
`
`xplain, as necessary, the foregoing items:
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`WNW\
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`£220.97
` ignature of Preparer
`Date
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`cc:
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`Orig NDA
`HFD-120 Division File
`N DA Action Package
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`Date: November 26, 1997
`
`Telecon with Paul Nemeth, PhD, Senior Director, Regulatory
`Affairs.
`145 Brandywine Parkway, West Chester, PA 19380—4245
`
`Reference: Scheduling and Abuse of Modafinil NDA #20—717
`Tel:
`(610) 344—0200
`
`Dr. Nemeth returned my earlier voice message call.
`
`I opened the discussion by informing Dr. Nemeth that the Jasinski'
`data made the drug look a lot like methylphenidate. Also,
`the
`drug self-administration data in primates was pretty compelling
`implying significant abuse and potential dependence producing
`properties.
`I asked how Cephalon would respond to a CIII
`recommendation, and told the sponsor that the similarity in study
`results of modafinil to methylphenidate and cocaine has led us to
`even consider CII as an option.
`
`I» '
`
`they
`Cephalon opposes C111, and “if could see into crystal ball,
`would request no scheduling.” Per Nemeth
`there are no reports
`of abuse.
`this is well
` .
`known, yet i
`as yet as far as
`as
` .
`they know.
`It is difficult to inject the drug or smoke it.
`The
`difference is because the type of substance abuse females differs
`from males;
`females abuse more Rx products.
`
`The drug substance comes from— and will be imiorted
` .
`into the U.S. Dosage forms will be manufactured in
` .
`There are no current plans for manufacturing the drug in US,
`that
`is, not until they look for “a big indication” specifically ADHD.
`
`Long developing plan
`they are planning ADHD studies.
`Next year,
`will have to show the effect on growth & development.
`Long term
`data is needed. A first study will involve 80 pediatric patients
`at doses of 100 mg start & go up a down 50 mg.
`Indication is
`tied to school year, because the diagnosis often comes from the
`school system.
`
`'
`
`““
`
`Nemeth will call back at 1PM, with Contreras (preclin) & Civil
`(clin). Nemeth said that a decision to request CIII could be
`made by this group since they are small enough of a company.
`
`1 PM Call Back:
`
`Two more consultants
`Later in the day the sponsor called back.
`(Jasinski & Cicero) were on the line.
`It was the Jasinski
`clinical abuse liability study — 14 volumes in total - that was
`submitted just prior to the deadline (two days prior) under PDUEA‘
`
`
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`without getting an extension for review as a major clinical
`amendment.
`The data came in to the FDA with a request for CIV.
`The drug showed significant gender differences in “drug liking”,
`as “amphetamine-like”, euphoria scale with an early peak effect.
`Responses over the next few hours increased significantly on the
`LSD scale.
`Jasinski maintained that modafinil was no more
`abuseable than phentermine (which is water soluble as opposed to
`modafinil). He would provide a demonstration of such; anorectic
`abuse he maintained is not likely and possible off-label use (for
`ADHD and staying awake for performance enhancement)
`is “not
`abuse, but misuse.”
`
`Jasinsik wanted to know what the driving force was for wanting
`the drug controlled more strictly.
`I responded that it was the
`similar pharmacology of modafinil to methyphenidate & cocaine in
`abuse liability studies, and fairness not just to this sponsor
`but to the sponsors of the comparator drugs that the drugs on the
`marketplace be regulated similarly if they are pharmacologically
`similar.
`
`Jasinski said that he would FEDEX me data to show that modafinil
`is comparable to phentermine which is in CIV. Unfortunately,
`such a direct comparison of modafinil to phentermine was not
`studied.
`
`APPEARS THIS WAY ON ORIGINAL
`APPEARS THIS WAY ON ORIGINAL
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`REQUEST FOR TRADEMARK REVIEW
`
`To:
`
`Labeling and Nomenclature Committee
`
`Attention: Dan Boring, Chair (HFD-530)
`9210 Corporate Blvd Room
`/S/
`
`1
`
`Thru:
`
`Paul Leber, M.D.w W 7‘5”?
`
`
`Director, DNDP
`(HFD-120)
`
`From:
`
`Division of Neuropharmacologic Drug Products (HFD-120)
`Attention: Melina Malandrucco, R.Ph
`,
`(Project Manager)
`(301)594-5526
`
`Date:
`
`July 23, 1997
`
`Subject:
`
`Request for re-evaluation of a Trademark for Proposed New Drug Product
`(Review from August 1996 enclosed)
`
`Proposed Trademark:
`
`PROVlGlL (modafinil tablets)
`
`NDA:20-717
`
`indication: Narcolepsy
`
`A response is requested as soon as possible. Thank you.
`
`Note:
`
`cc.
`
`Original NDA 20-717
`HFD-120/Division Files
`HFD-120/Katz/Rappaport
`HFD-120/Blum/Heimann
`
`/S/
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`Consult #630 (HFD-IZO)
`
`PROVIGIL
`
`no established name
`
`A review revealed several names which sound like or look like the proposed name: Proventil,
`Provera The Committee does not believe there is a significant potential for confusion involving
`these names with the proposed name.
`
`A discussion was held on whether or not the proposed name was fanciful as defined in 21 CFR
`201 . 10(c)(3). The Committee notes that the indication for this product is for the treatment of
`narcolepsy, and that the name could imply " for wakefulness" (PRO = for, VIGIL = wakefulness).
`However, the Committee does not believe that the proposed name is misleading or fanciful in this
`respect
`
`The Committee has no reason to find the proposed name unacceptable at this time but reserves their
`recommendation until after a USAN is selected and the proposed non-prOprietary name is
`submitted to the Committee for reconsideration. Furthermore, the Committee notes the proposed
`name has been submitted for review very early in the review process (IND stage). Under such
`circumstances, the Committee routinely recommends the proposed name be re-evaluated once an
`NBA has been submitted and the application is closer to approval since the universe of potential
`sound—alike/look-alike proprietary names is constantly changing.
`
`/S/
`
`
`
`APPEARS THIS WAY ON ORIGINAL
`APPEARS THIS WAY ON ORIGINAL
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