`
`NDA 205580/S-012
`
`SUPPLEMENT APPROVAL
`
`
`
`Eagle Pharmaceuticals, Inc
`Attention: Kushal Desai
`Associate Director, Regulatory Affairs
`50 Tice Boulevard
`Suite 315
`Woodcliff Lake, NJ 07677
`
`
`
`Dear Mr. Desai:
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`December 2, 2021, submitted under section 505(b)(2) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for BELRAPZO™ (bendamustine hydrochloride injection).
`
`
`This Prior Approval supplemental new drug application provides for changes to the
`carton and package insert labeling as requested by the Agency.
`
`
`APPROVAL & LABELING
`
`
`We have completed our review of this supplemental application. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`
`CONTENT OF LABELING
`
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Content of labeling must be identical to the enclosed labeling (text for the prescribing
`information, and text for the patient package insert) with the addition of any labeling
`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
`reportable changes not included in the enclosed labeling.
`
`Information on submitting SPL files using eLIST may be found in the guidance for
`industry titled SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
`nces/UCM072392.pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`NDA 205580/S-012
`Page 2
`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
`reportable changes, and annotate each change. To facilitate review of your submission,
`provide a highlighted or marked-up copy that shows all changes, as well as a clean
`Microsoft Word version. The marked-up copy should provide appropriate annotations,
`including supplement number(s) and annual report date(s).
`
`
`CARTON AND CONTAINER LABELS
`
`
`Submit final printed carton and container labels that are identical to enclosed carton and
`container labels, as soon as they are available, but no more than 30 days after they are
`printed. Please submit these labels electronically according to the guidance for industry
`Providing Regulatory Submissions in Electronic Format – Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Product
`Correspondence – Final Printed Carton and Container Labels for approved NDA
`205580/S-012.” Approval of this submission by FDA is not required before the labeling
`is used.
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Chelsea Bostic, Regulatory Business Process Manager,
`at (301) 796 - 8862.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Ramesh Raghavachari, PhD
`Chief, Branch I
`Division of Post-Marketing Activities I
`Office of Lifecycle Drug Products
`Office of Pharmaceutical Quality
`Center for Drug Evaluation and Research
`
`
`
`
`Enclosure(s):
`
`Content of Labeling
`Carton and Container Labeling
`
`
`
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`Ramesh
`Raghavachari
`
`Digitally signed by Ramesh Raghavachari
`Date: 6/02/2022 03:20:31PM
`GUID: 502d0913000029f375128b0de8c50020
`
`(
`
`
`
`