Azurity Pharmaceuticals, Inc.Zonisade (zonisamide) oral suspension, 20 mg/mL, 150 mL Fill

NDA 214273 COMPLETE RESPONSE

Azurity Pharmaceuticals, Inc.

Attention: Bharathi Devarakonda, Ph.D., RAC

Senior Vice President, Product Development & Regulatory Affairs 21925 West Field Parkway, Suite 235

Deer Park, IL 60010

Dear Dr. Devarakonda:

Please refer to your new drug application (NDA) dated July 29, 2020, received July 29, 2020, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Zonisade (zonisamide) oral suspension, 20 mg/mL, 150 mL Fill.

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

1. During a recent inspection of the oO (FEI: ©® manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved.

2. During a review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, we communicated issues with the L M MANUFACTURING LIMITED, FEI 3015337531 manufacturing facility named in your application. These issues will need to be addressed in order to for your application to be approved. An inspection of the LM MANUFACTURING LIMITED, FEI 3015337531 facility is required before the application can be approved. FDA must ensure that the facility is able to conduct the listed manufacturing operations in compliance with Current Good Manufacturing Practice (CGMP) regulations. Due to restrictions on travel, we were unable to conduct an inspection during the current review cycle for your application. You may respond to deficiencies in this Complete Response Letter while the travel restrictions remain in effect. However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspection is conducted and any findings are assessed with regard to your application. We will continue to monitor the public health situation as well as travel restrictions. We

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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.

3. For more information, please see the FDA guidances related to COVID-19.' 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.

CARTON AND CONTAINER LABELING

Submit draft carton and container labeling based on our proposed revisions dated January 29, 2021.

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 our correspondence dated February 8, 2021, which addresses the proposed proprietary name, Zonisade. 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.

SAFETY UPDATE

When you respond to the above deficiencies, include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b). The safety update should include data from all nonclinical

’ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-201 9-covid-19/covid- 19-related-quidance-documents-industry-fda-staff-and-other-stakeholders

2 http:/www.fda.gov/Drugs/GuidanceComplianceRegulatory|Information/LawsActsandRules/ucm08415 9.htm

3 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm09330 Zhtm

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

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and clinical studies/trials of the drug under consideration regardless of indication, dosage form, or dose level.

1.

2.

Describe in detail any significant changes or findings in the safety profile.

When assembling the sections describing discontinuations due to adverse events, serious adverse events, and common adverse events, incorporate new safety data as follows:

e Present new safety data from the studies/clinical trials for the proposed indication using the same format as in the original submission.

e Present tabulations of the new safety data combined with the original application data.

e Include tables that compare frequencies of adverse events in the original application with the retabulated frequencies described in the bullet above.

e For indications other than the proposed indication, provide separate tables for the frequencies of adverse events occurring in Clinical trials.

Present a retabulation of the reasons for premature trial discontinuation by incorporating the drop-outs from the newly completed trials. Describe any new trends or patterns identified.

Provide case report forms and narrative summaries for each patient who died during a Clinical trial or who did not complete a trial because of an adverse event. In addition, provide narrative summaries for serious adverse events.

Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the original application data.

Provide updated exposure information for the clinical studies/trials (e.g., number of subjects, person time).

Provide a summary of worldwide experience on the safety of this drug. Include an updated estimate of use for drug marketed in other countries.

Provide English translations of current approved foreign labeling not previously submitted.

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

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OTHER

Within one 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 Stephanie N. Parncutt, M.H.A., Senior Regulatory Health Project Manager, via telephone at (301) 796-4098 or via email at Stephanie.Parncutt@fda.hhs.gov.

Sincerely, {See appended electronic signature page}

Nick Kozauer, M.D.

Director

Division of Neurology 2

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.

NICHOLAS A KOZAUER 05/28/2021 11:50:54 AM

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