NDA 212640/S-001
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`
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`SUPPLEMENT APPROVAL
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`
`Aquestive Therapeutics
`Attention: Mr. Daniel Barber
`Chief Operating Officer
`30 Technology Drive
`Warren, NJ 07059
`
`
`Dear Mr. Barber:
`
`Please refer to your supplemental new drug application (sNDA) dated April 24, 2020,
`received April 27, 2020, submitted pursuant to section 505(b)(2) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Exservan (riluzole) Oral Film.
`
`This “Changes Being Effected” supplemental new drug application provides for the
`addition of pancreatitis as an adverse reaction under Section 6.2 Postmarketing
`Experience.
`
`APPROVAL & LABELING
`
`We have completed our review of this application. 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), with the addition of any labeling
`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
`reportable changes not included in the enclosed labeling. If the content of labeling in
`SPL format initially submitted with this CBE-0 labeling supplement is identical to the
`attached approved labeling, an additional submission of content of labeling in SPL
`
`format is not required.
`
`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
`
`
`
`
`
` 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: 4605598
`
`

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`NDA 212640/S-001
`Page 2
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include labeling
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`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
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`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 none of these criteria apply to your application, you are exempt from this
`requirement.
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`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
`
`Director (Acting)
`Division of Neurology 1
`Office of Neuroscience
`Center for Drug Evaluation and Research
`
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`ENCLOSURE:
` Content of Labeling
`
`o Prescribing Information
`
`o
`Instructions for Use
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4605598
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`

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`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.
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`/s/
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`ERIC P BASTINGS
`05/11/2020 08:34:31 AM
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`Reference ID: 4605598
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