Eagle Pharmaceuticals, Inc.Fulvestrant Injection

NDA 220045 COMPLETE RESPONSE

Eagle Pharmaceuticals, Inc.

Attention: Janis A. Picurro

Senior Vice President, Regulatory Affairs 50 Tice Boulevard, Suite 315

Woodcliff Lake, NJ 07677

Dear Janis Picurro:

Please refer to your new drug application (NDA) dated March 14, 2025, received March 14, 2025, and your amendments, submitted pursuant to for Fulvestrant Injection.

We acknowledge receipt of your major amendment dated November 18, 2025, 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.

FACILITY INSPECTIONS Following a CGMP inspection of me,

isted in this application, we conveyed deficiencies to the representative of the facility. The facility should provide satisfactory responses to these deficiencies to our office indicated on the FDA Form 483 prior to your complete response. The facility's satisfactory responses are dependent on our 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 pending 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, we may need to conduct a 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.

Reference ID: 5779649

NDA 220045 Page 2

PRESCRIBING INFORMATION

We acknowledge the draft labeling submitted on March 6, 2026, in response to our March 5, 2026, information request. Please resubmit labeling when you respond to this

Complete Response letter.

Prior to resubmitting the labeling, use the SRPI checklist to correct any formatting errors to ensure conformance with the format items in regulations and guidances. In addition, submit updated content of labeling [21 CFR 314.50(I)(1)(i)] in structured product labeling

(SPL) format as described at FDA.gov.1

To facilitate review of your submission, provide a highlighted or marked-up copy that shows all changes, as well as a clean Word version. The marked-up copy should include annotations that support any proposed changes.

Your proposed Prescribing Information (PI) must conform to the content and format regulations found at 21 CFR 201.56(a) and (d) and 201.57. As you develop your proposed PI, we encourage you to review the labeling review resources on the Prescription Drug Labeling Resources2 and Pregnancy and Lactation Labeling Final

Rule? websites, which include:

e The Final Rule (Physician Labeling Rule) on the content and format of the Pl

for human drug and biological

products

e The Final Rule (Pregnancy and Lactation Labeling Rule) on the content and

format of information in the P males of reproductive potential

on pregnancy, lactation, and females and

e Regulations and related guidance documents

e Asample tool illustrating the

‘ormat for Highlights and Contents, and

e The Selected Requirements for Prescribing Information (SRPI) - a checklist of important format items from labeling regulations and guidances.

e FDA's established pharmaco!

logic class (EPC) text phrases for inclusion in the

Highlights Indications and Usage heading.

e Additional resources for the PI, patient labeling, and carton/container labeling.

| http://www.fda.gov/ForIndustry/DataS tandards/StructuredProductLabeling/default.htm

2 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources

3 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-final-rule

U.S. Food and Drug Administration

Silver Spring, MD 20993 www.fda.gov

Reference ID: 5779649

NDA 220045 Page 3

CARTON AND CONTAINER LABELING

When you respond to this Complete Response letter, please resubmit carton and container labeling that is identical to the carton and container labeling submitted on February 12, 2026, and November 14, 2025, respectively.

PROPRIETARY NAME

Please refer to our correspondence dated May 21, 2025, which addresses the proposed proprietary name, {"). This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to all of the application deficiencies that have been identified in this letter.

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

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

(2) 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.

(3) 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.

(4) Provide case report forms and narrative summaries for each subject 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.

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

Reference ID: 5779649

NDA 220045 Page 4

(5) 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.

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

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

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

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 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 guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.

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

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

Reference ID: 5779649

NDA 220045

Page 5 If you have any questions, contact

Sincerely,

{See appended electronic signature page}

Center for Drug Evaluation and Research

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

Reference ID: 5779649

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.

(b) (4)

04/13/2026 11:07:27 AM

(b) (4)

Reference ID: 5779649