CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICATION NUMBER:
`
` 212640Orig1s000
`
` Exservan oral film, 50 mg
`
`Trade Name:
`
`
`
`Generic or Proper
`Name:
`
`Sponsor:
`
`
`
`
`Approval Date:
`
`Indication:
`
`
`
`
`(riluzole)
`
`Aquestive Therapeutics
`
`
`
`November 22, 2019
`For the treatment of amyotrophic lateral sclerosis (ALS)
`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`212640Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
`
`X
`X
`
`
`X
`X
`
`
`
`X
`X
`
`X
`
`
`

`

`
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`212640Orig1s000
`
`
`APPROVAL LETTER
`
`

`

`NDA 212640
`
`
`
`NDA APPROVAL
`
`
`Aquestive Therapeutics
`Attention: Leann M. Clymer, Esq.
`Regulatory Affairs
`30 Technology Drive
`Warren, NJ 07059
`
`
`Dear Ms. Clymer:
`
`Please refer to your new drug application (NDA) dated January 31, 2019, and received
`January 31, 2019, and your amendments, submitted pursuant to section 505(b)(2) of
`the Federal Food, Drug, and Cosmetic Act (FDCA) for Exservan (riluzole) oral film,
`50 mg.
`
`This new drug application provides for the use of Exservan (riluzole) oral film for the
`treatment of amyotrophic lateral sclerosis (ALS).
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information and Instructions for Use) as well as annual reportable changes
`not included in the enclosed labeling. Information on submitting SPL files using eLIST
`may be found in the guidance for industry SPL Standard for Content of Labeling
`Technical Qs and As.2
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`Reference ID: 4524184
`
`

`

`NDA 212640
`Page 2
`
`
`CARTON AND CONTAINER LABELING
`
`Submit final printed carton and container labeling that are identical to the container
`labeling submitted on September 25, 2019, and the carton labeling submitted on
`October 25, 2019, as soon as they are available, but no more than 30 days after they
`are printed. Please submit these labeling electronically according to the guidance for
`industry Providing Regulatory Submissions in Electronic Format — Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
`Carton and Container Labeling for approved NDA 212640.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because this drug product for this indication has an orphan drug designation, you are
`exempt from this requirement.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit, in triplicate, a cover letter requesting advisory
`comments, the proposed materials in draft or mock-up form with annotated references,
`and the Prescribing Information, Medication Guide, and Patient Package Insert (as
`applicable) to:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD
`format. For more information about submitting promotional materials in eCTD format,
`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4524184
`
`

`

`NDA 212640
`Page 3
`
`
`Non-Electronic Format—Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
`and the Prescribing Information, at the time of initial dissemination or publication,
`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
`Information and Instructions for completing the form can be found at FDA.gov.5 For
`more information about submission of promotional materials to the Office of Prescription
`Drug Promotion (OPDP), see FDA.gov.6
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, contact Michelle Mathers, Regulatory Project Manager, at
`michelle.mathers@fda.hhs.gov or at (240) 402-2645.
`
`
`Sincerely,
`
`{See appended electronic signature
`page}
`
`Eric Bastings, MD
`Acting Director
`Division of Neurology 1
`Office of Neuroscience
`Office of New Drugs
`
`
`
`ENCLOSURES:
` Content of Labeling
`o Prescribing Information
`o
`Instructions for Use
`
`
`
`
`3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4524184
`
`

`

`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ERIC P BASTINGS
`11/22/2019 02:36:43 PM
`
`Reference ID: 4524184
`
`