Evergreen Theragnostics, Inc.Kit for the Preparation of Gallium Ga Edotreotide Injection

NDA 216900 COMPLETE RESPONSE

Evergreen Theragnostics, Inc.

C/o Bourque Regulatory CMC, Inc. Attention: Mr. Jeffrey Bourque

President, Bourque Regulatory CMC, Inc. 27 Commerce Street

Springfield, NJ 07081

Dear Mr. Jeffrey Bourque:

Please refer to your new drug application (NDA) dated September 20, 2022, received September 20, 2022, and your amendments, submitted pursuant to

for Kit for the Preparation of Gallium Ga Edotreotide Injection

We acknowledge receipt of your amendment dated September 29, 2025, which constituted a complete response to our October 18, 2023, action letter.

We acknowledge receipt of your major amendment dated March 11, 2026, which extended the goal date by three months.

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.

PRODUCT QUALITY

Reference ID: 5822725

NDA 216900 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 Prescription Drug Labeling Resources! 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

We reserve comment on the proposed labeling until the application is otherwise adequate.

PROPRIETARY NAME

Please refer to correspondence dated, December 9, 2022, which addresses the proposed proprietary name, |"). 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.

FACILITY INSPECTIONS oa

, aS listed in this application, FDA conveyed deficiencies to the representative of the facility. The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response. The facility's satisfactory responses are dependent on FDA’s determination that the facility has come into compliance with CGMP and may require re- inspection of the facility. The deficiencies identified during the inspection may not be specific to your application. Therefore, you should coordinate with the facility for timely resolution. Your complete response should include the date(s) of the facility's response(s) to the FDA Form 483. Please refer to Compliance Program CP 7356.002 for guidance on post-inspection activities. Following resolution of the CGMP inspection, FDA may need to conduct a pre-approval inspection (PAI) of the facility. Satisfactory outcomes of both the PAI and the CGMP surveillance inspections will be needed prior to an approval of the application.

Following a CGMP inspection of

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final-rule

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, please contact sy

Sincerely,

{See appended electronic signature page}

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Center for Drug Evaluation and Research Food and Drug Administration

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.

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06/26/2026 08:37:25 AM

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