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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 208194
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`Food and Drug Administration
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` Silver Spring MD 20993
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`NDA APPROVAL
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` Eagle Pharmaceuticals, Inc.
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` Attention: Foma Rashkovsky
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` Senior Director, Regulatory Affairs
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` 50 Tice Boulevard, Suite 315
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` Woodcliff Lake, NJ 07677
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`Dear Mr. Rashkovsky:
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`Please refer to your New Drug Application (NDA) dated February 13, 2015, received February
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`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
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`(25 mg/mL).
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`We also refer to our approval letter dated December 7, 2015 which contained the following error:
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`the incorrect versions of the carton and vial labels were attached.
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`This replacement approval letter incorporates the correction of the error. The effective approval
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`date will remain December 7, 2015, the date of the original approval letter.
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`This new drug application provides for the use of Bendeka (bendamustine hydrochloride)
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`Injection, 100 mg/4 mL (25 mg/mL), for treatment of patients with chronic lymphocytic
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`leukemia (CLL) and treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL)
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`that has progressed during or within six months of treatment with rituximab or a rituximab
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`containing regimen.
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`We have completed our review of this application, as amended. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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`A shelf life of 24 months is granted for Bendeka (bendamustine hydrochloride) Injection, when
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`stored refrigerated at 2 - 8ºC (36 - 46ºF), protected from light.
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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 content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`Reference ID: 3858324
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` NDA 208194
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` Page 2
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` of labeling must be identical to the enclosed labeling (text for the package insert). Information
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` on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for
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` Content of Labeling Technical Qs and As, available at
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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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 the enclosed
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`carton and immediate container labels as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labels electronically according to the guidance for
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`industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical
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`Product Applications and Related Submissions Using the eCTD Specifications (June 2008).
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`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
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`submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
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`the product misbranded and an unapproved new drug.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because this drug product for these indications have orphan drug designation, you are exempt
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`from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
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`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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` NDA 208194
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` Page 3
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` OPDP Regulatory Project Manager
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` Food and Drug Administration
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` Center for Drug Evaluation and Research
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` Office of Prescription Drug Promotion
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` 5901-B Ammendale Road
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` Beltsville, MD 20705-1266
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`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
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` Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf).
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
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`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
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`2253. Form FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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 Laura Wall, Regulatory Project Manager, at (301) 796-2237.
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`Sincerely,
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`{See appended electronic signature page}
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`Edvardas Kaminskas, MD
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`Deputy Director
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`Division of Hematology Products
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`Office of Hematology and Oncology Products
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`Center for Drug Evaluation and Research
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`Enclosures:
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`Content of Labeling
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`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/
`----------------------------------------------------
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`EDVARDAS KAMINSKAS
`12/07/2015
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`Reference ID: 3858324
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