CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICA TI0N NUMBER:
`
`2055800rig18000
`
`Trude Name:
`
`Belrapzo
`
`Generic 01‘1’1‘01’9" Bendamustine hydrochloride injection, 100 mg/4 mL
`Nam“
`(25 mg/mL)
`
`Sponsor:
`
`Eagle Pharmaceuticals, Inc.
`
`Approval Date:
`
`May 1 5 ’ 201 8
`
`Indication:
`
`Treatment of patients with:
`
`0 Chronic lymphocytic leukemia (CLL). Efficacy relative
`to first line therapies other than chlorambucil has not
`been established.
`
`0 Indolent-B-cell non-Hodgkin lymphoma (NHL) that has
`progressed during or within six months of treatment With
`rituximab or a rituximab-containing regimen.
`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`205580Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`X
`X
`X
`
`X
`X
`
`
`X
`X
`X
`
`X
`X
`
`X
`X
`
`

`

`
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`205580Orig1s000
`
`
`APPROVAL LETTER
`
`

`

`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 205580
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`
`Eagle Pharmaceuticals, Inc.
`Attention: Robert Ashworth, PhD
`Senior Vice President, Regulatory Affairs
`50 Tice Boulevard, Suite 315
`Woodcliff Lake, NJ 07677
`
`
`Dear Dr. Ashworth:
`
`Please refer to your New Drug Application (NDA) dated September 6, 2013, received
`September 6, 2013, and your amendments, submitted pursuant to section 505(b)(2) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for bendamustine hydrochloride injection, 100 mg/4 mL
`(25 mg/mL).
`
`We acknowledge receipt of your amendments dated January 31, 2018 and April 4, 2018, which
`constituted a response to our July 2, 2014 and March 30, 2018, Tentative Approval action letters,
`respectively.
`
`
`This new drug application provides for the use of bendamustine hydrochloride injection for
`treatment of patients with:
`
`
`• Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies
`other than chlorambucil has not been established.
`Indolent-B-cell non-Hodgkin lymphoma (NHL) that has progressed during or
`within six months of treatment with rituximab or a rituximab-containing regimen.
`
`•
`
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`WAIVER OF HIGHLIGHTS SECTION
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
`
`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
`
`Reference ID: 4263446
`
`

`

`NDA 205580
`Page 2
`
`
`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).
`Information on submitting SPL files using eLIST may be found in the guidance for industry SPL
`Standard for Content of Labeling Technical Qs and As, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to the carton and
`immediate container labels submitted on March 20, 2018, 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 titled Providing Regulatory Submissions in Electronic Format —
`Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications (May 2015, Revision 3). For administrative purposes, designate this submission
`“Final Printed Carton and Container Labels for approved NDA 205580.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`PROPRIETARY NAME
`
`If you intend to have a proprietary name for this product, the name and its use in the labels must
`conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit
`a request for a proposed proprietary name review. (See the guidance for industry Contents of a
`Complete Submission for the Evaluation of Proprietary Names, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/u
`cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
`2008 through 2012”.)
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients (which includes new salts and new fixed combinations), new indications, new
`dosage forms, new dosing regimens, or new routes of administration are required to contain an
`assessment of the safety and effectiveness of the product for the claimed indication in pediatric
`patients unless this requirement is waived, deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable.
`
`
`Reference ID: 4263446
`
`

`

`NDA 205580
`Page 3
`
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the prescribing
`information, Medication Guide, and patient PI (as applicable) to:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf).
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`prescribing information, at the time of initial dissemination or publication, accompanied by a
`Form FDA 2253. Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`Reference ID: 4263446
`
`

`

`NDA 205580
`Page 4
`
`
`If you have any questions, call Laura Wall, Regulatory Project Manager, at (301) 796-2237.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`R. Angelo de Claro, MD
`Acting Deputy Director
`Division of Hematology Products
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
`
`
`
`Enclosure:
`Content of Labeling
`
`
`
`Reference ID: 4263446
`
`

`

`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ROMEO A DE CLARO
`05/15/2018
`
`Reference ID: 4263446
`
`(
`
`
`
`