Tris Pharma, Inc.Dyanavel XR (amphetamine) extended-release tablets 5 mg, 10 mg, 15 mg, and 20 mg

NDA 210526 COMPLETE RESPONSE

Tris Pharma, Inc.

Attention: Norma J. Cappetti

Vice President, Regulatory Affairs 2033 Route 130, Suite D Monmouth Junction, NJ 08852

Dear Ms. Cappetti:

Please refer to your New Drug Application (NDA) dated and received September 25, 2017, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Dyanavel XR (amphetamine) extended-release tablets 5 mg, 10 mg, 15 mg, and 20 mg.

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 Tris Pharma, Inc. (FEI: 3004712471) 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.

REGULATORY

2. Your 505(b)(2) application relies upon the Agency’s finding of safety and effectiveness for NDA 011522 for Adderall Tablets for which you submitted Paragraph IV certification with respect to U.S. Patent Number 6,384,020 (‘020 patent), listed in FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) as described in 21 CFR 314.54(a)(1)(vi). However, you have not provided documentation of receipt by each person identified in 21 CFR 314.52(a) of the required notice of Paragraph IV certification for the ‘020 patent. Acceptable forms of documentation are described in 21 CFR 314.52(e). You are also reminded that you must notify FDA within 14 days of the filing of any legal action filed within 45 days of receipt of the notice of Paragraph IV certification by any recipient, if applicable (see 21 CFR 314.107(f)(2)).

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PRESCRIBING INFORMATION

3. 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(1)(1)(i)] in structured product labeling (SPL) format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

CARTON AND CONTAINER LABELING 4. Submit draft carton and container labeling revised as follows:

We note the size of the established name has been increased on the revised container labels submitted on July 12, 2018. However, the established name is now too prominent relative to the proprietary name. Decrease the size of the established name so that it is 2 the size of the proprietary name. Consider increasing the size of the proprietary name while decreasing the size of the established name.

MEDICATION GUIDE

5. 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

6. Please refer to correspondence dated April 16, 2018, which addresses the proposed proprietary name, Dyanavel XR. 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.

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.

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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 this 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 take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft FDA Guidance for Industry, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” December 2017 at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM59054 1.

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

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

Sincerely, {See appended electronic signature page}

Mitchell Mathis, MD

Director

Division of Psychiatry Products

Office of Drug Evaluation I

Center for Drug Evaluation and Research

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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.

MITCHELL V Mathis 07/25/2018

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