Supernus Pharmaceuticals, Inc.viloxazine hydrochloride extended-release capsules

NDA 211964 COMPLETE RESPONSE

Supernus Pharmaceuticals, Inc. Attention: Tami Martin, RN, Esq. Vice President, Regulatory Affairs 1550 East Gude Drive

Rockville, MD 20850

Dear Ms. Martin:

Please refer to your new drug application (NDA) dated November 8, 2019, received November 8, 2019, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for viloxazine hydrochloride extended-release capsules.

We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues.

FACILITY INSPECTIONS

During a review of records requested under FD&C act section 704(a)(4) provided by Supernus (FEI: 3005209462) manufacturing facility, FDA noted objectionable conditions. These objectionable conditions will be conveyed to the representative of the facility within 10 business days of this Complete Response Letter. Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection or adequate facility responses addressing these conditions) before this application may be approved.

If it is determined that an inspection is needed to approve your application, please note that FDA continues to monitor the public health situation as well as travel restrictions. We are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.

For more information, please see the FDA guidances related to COVID 19. These guidances can be found at https://www.fda.gov/emergency-preparedness-and- response/coronavirus-disease-2019-covid-19/covid-19-related-quidance-documents- industry-fda-staff-and-other-stakeholders.

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NDA 211964 Page 2

PRESCRIBING INFORMATION

We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the PLR Requirements for Prescribing Information’ and Pregnancy and Lactation Labeling Final Rule? websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) - a checklist of important format items from labeling regulations and guidances.

If you revise labeling, use the SRPI checklist to ensure that the Prescribing Information conforms with format items in regulations and guidances. Your response must include updated content of labeling [21 CFR 314.50(I)(1)(i)] in structured product labeling (SPL) format as described at FDA.gov.°

CARTON AND CONTAINER LABELING

The Office of Pharmaceutical Quality (OPQ) finds the label attached to your November 5, 2020, email correspondence not acceptable from a Chemistry, Manufacturing, and Controls perspective, and we recommend the label be revised as follows:

Each capsule contains: Viloxazine....... 150 mg (equivalent to 173 mg of viloxazine hydrochloride)

For more information, you may refer to the FDA Guidance Naming of Drug Products Containing Salt Drug Substances.

MEDICATION GUIDE

Add the following bolded statement or appropriate alternative to the carton and container labels per 21 CFR 208.24(d): "ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide."

PROPRIETARY NAME

Please refer to correspondence dated, November 5, 2020, which addresses the proposed proprietary name, Qelbree. This name was found acceptable, pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.

1 http://www.fda.gov/Drugs/GuidanceComplianceRegulatory|nformation/LawsActsandRules/ucm08415 9.htm 2 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm09330 7.htm 3 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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NDA 211964 Page 3

OTHER

Within 1 year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under

21 CFR 314.65. You may also request an extension of time in which to resubmit the application.

A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider

his resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to ‘ake before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.

The drug product may not be legally marketed until you have been notified in writing hat this application is approved.

If you have any questions, contact CAPT Kofi Ansah, PharmD, Senior Regulatory Project Manager, at (301)796-4158 or email: Kofi.Ansah@fda.hhs.gov.

Sincerely,

{See appended electronic signature page} Eric Bastings, MD

Deputy Director

Office of Neuroscience Center for Drug Evaluation and Research

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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Signature Page 1 of 1

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.

ERIC P BASTINGS 11/06/2020 07:56:33 PM

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