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` NDA 209472/S-001
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`SUPPLEMENT APPROVAL
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`Eagle Pharmaceuticals, Inc.
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`Attention: Janis Picurro
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`Senior Vice President, Regulatory Affairs
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`50 Tice Boulevard, Suite 315
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`Woodcliff Lake, NJ 07677
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`Dear Ms. Picurro:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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`February 21, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Pemfexy (pemetrexed injection).
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`This Prior Approval supplemental new drug application provides for the labeling change
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`from single-dose vial to multiple-dose vial for the Pemfexy® (pemetrexed injection),
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`500 mg/20 mL (25 mg/mL).
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is
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`approved, effective on the date of this letter, for use as recommended in the enclosed
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`agreed-upon labeling text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Content of labeling must be identical to the enclosed labeling (text for the prescribing
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`information) with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the
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`enclosed labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for
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`industry titled SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
`nces/UCM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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` U.S. Food & Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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` NDA 209472/S-001
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` Page 2
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` action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format,
` that includes the changes approved in this supplemental application, as well as annual
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` reportable changes, and annotate each change. To facilitate review of your submission,
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` provide a highlighted or marked-up copy that shows all changes, as well as a clean
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` Microsoft Word version. The marked-up copy should provide appropriate annotations,
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` including supplement number(s) and annual report date(s).
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to enclosed
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`carton and immediate container labels, as soon as they are available, but no more than
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`30 days after they are printed. Please submit these labels electronically according to
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`the guidance for industry Providing Regulatory Submissions in Electronic Format –
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications (May 2015, Revision 3). For administrative purposes, designate this
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`submission “Product Correspondence – Final Printed Carton and Container Labels
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`for approved NDA 209472/S-001.” Approval of this submission by FDA is not required
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`before the labeling is used.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Jessica Springer, Regulatory Business Process
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`Manager, at (240) 402 - 5926.
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`Sincerely,
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`{See appended electronic signature page}
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`Ramesh Raghavachari, Ph.D.
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`Chief, Branch I
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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`Enclosure(s):
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`Content of Labeling
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`Carton and Container Labeling
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` U.S. Food & Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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`Ramesh
`Raghavachari
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`Digitally signed by Ramesh Raghavachari
`Date: 6/17/2020 02:58:11PM
`GUID: 502d0913000029f375128b0de8c50020
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`(
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