DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 208194
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

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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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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

Enclosures:
Content of Labeling
Carton and Container Labeling

Reference ID: 3858324

 --------------------------------------------------------------------------------------------------------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