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`Trade Name:
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`Generic Name:
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`Approval Package for:
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`APPLICATION NUMBER:
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` 208194Orig1s000
`
`
` BendekaTM Injection, 100 mg/4 mL (25 mg/mL)
`
`bendamustine hydrochloride
`
`Eagle Pharmaceuticals, Inc.
`
`December 7, 2015
`
`For treatment of patients with chronic lymphocytic
`leukemia (CLL) and treatment of patients with indolent
`B-cell non-Hodgkin lymphoma (NHL) that has
`progressed during or within six months of treatment with
`rituximab or a rituximab containing regimen.
`
`
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`Sponsor:
`
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`Approval Date:
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`Indication:
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`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`208194Orig1s000
`
`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
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
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`X
`
`X
`X
`
`X
`X
`X
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`X
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`X
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`X
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`X
`X
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`

`

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`
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`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`208194Orig1s000
`
`
`APPROVAL LETTER
`
`

`

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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`
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`
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`NDA 208194
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`
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`
`
`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
`
`
`
`Eagle Pharmaceuticals, Inc.
`Attention: Foma Rashkovsky
`Senior Director, Regulatory Affairs
`50 Tice Boulevard, Suite 315
`Woodcliff Lake, NJ 07677
`
`
`Dear Mr. Rashkovsky:
`
`Please refer to your New Drug Application (NDA) dated February 13, 2015, received February
`13, 2015, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food,
`Drug, and Cosmetic Act for BendekaTM (bendamustine hydrochloride) Injection, 100 mg/4 mL
`(25 mg/mL).
`
`We also refer to our approval letter dated December 7, 2015 which contained the following error:
`the incorrect versions of the carton and vial labels were attached.
`
`This replacement approval letter incorporates the correction of the error. The effective approval
`date will remain December 7, 2015, the date of the original approval letter.
`
`This new drug application provides for the use of Bendeka (bendamustine hydrochloride)
`Injection, 100 mg/4 mL (25 mg/mL), for treatment of patients with chronic lymphocytic
`leukemia (CLL) and treatment of patients with 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.
`
` A
`
` shelf life of 24 months is granted for Bendeka (bendamustine hydrochloride) Injection, when
`stored refrigerated at 2 - 8ºC (36 - 46ºF), protected from light.
`
`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
`
`Reference ID: 3858324
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`

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`NDA 208194
`Page 2
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`of labeling must be identical to the enclosed labeling (text for the package insert). 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 enclosed
`carton and immediate 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 – Human Pharmaceutical
`Product Applications and Related Submissions Using the eCTD Specifications (June 2008).
`Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on
`heavy-weight paper or similar material. For administrative purposes, designate this submission
`“Final Printed Carton and Container Labels for approved NDA 208194.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, 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(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`Because this drug product for these indications have orphan drug designation, you are exempt
`from this requirement.
`
`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 package insert,
`Medication Guide, and patient PI (as applicable) to:
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`Reference ID: 3858324
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`

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`NDA 208194
`Page 3
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`
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`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
`package insert, 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).
`
`If you have any questions, call Laura Wall, Regulatory Project Manager, at (301) 796-2237.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Edvardas Kaminskas, MD
`Deputy Director
`Division of Hematology Products
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
`
`
`
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`Enclosures:
`Content of Labeling
`Carton and Container Labeling
`
`
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`Reference ID: 3858324
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`EDVARDAS KAMINSKAS
`12/07/2015
`
`Reference ID: 3858324
`
`(
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