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`
`Attention: Janis A. Picurro
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`Senior Vice President, Regulatory Affairs
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`50 Tice Boulevard, Suite 315
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`Woodcliff Lake, NJ 07677
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`
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`Dear Ms. Picurro:
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`
`Please refer to your supplemental new drug application (sNDA) dated
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`October 22, 2019, received October 22, 2019, submitted pursuant to section 505(b)(2)
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`of the Federal Food, Drug, and Cosmetic Act (FDCA) for BENDEKA® (bendamustine
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`hydrochloride injection.)
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`This “Changes Being Effected” supplemental new drug application provides for:
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`1)
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`In the Table of Contents, the name in subsection 6.1 was corrected to read
`“Clinical Trials Experience” to match the subheading name in 6.1 in the Full
`Prescribing Information.
`In the Full Prescribing Information, subsection 6.1 Clinical Trials Experience, the
`following text was added as the first paragraph: “Because clinical trials are
`conducted under widely varying conditions, adverse reaction rates observed in
`the clinical trials of a drug cannot be directly compared to rates in the clinical
`trials of another drug and may not reflect the rates observed in practice.”
`In the Full Prescribing Information, subsection 12.3 Pharmacokinetics,
`Metabolism, the word “bendamustine” was capitalized.
`
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`
`NDA 208194/S-020
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`
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`SUPPLEMENT APPROVAL
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`2)
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`3)
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`Reference ID: 4518170
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`
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`NDA 208194/S-020
`Page 2
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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
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`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information), with the addition of any labeling changes in pending “Changes
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`in the enclosed labeling.
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`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.2
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`The SPL will be accessible from publicly available labeling repositories.
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`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
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
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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 active ingredients (which includes new salts and new fixed combinations), new
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`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.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
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`
`
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`
`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4518170
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`
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`NDA 208194/S-020
`Page 3
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter
`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
`annotated references, and (3) the Prescribing Information to:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`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 Providing Regulatory Submissions in Electronic and
`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5 For more information
`about submission of promotional materials to the Office of Prescription Drug Promotion
`
` (OPDP), see FDA.gov.6
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`REPORTING REQUIREMENTS
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`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`
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`
`
`
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`3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
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`U.S. Food and Drug Administration
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`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4518170
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`
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`NDA 208194/S-020
`Page 4
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`If you have any questions, call Laura Wall, Senior Regulatory Project Manager, at
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`301-796-2237.
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`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Ann T. Farrell, MD
`Director
`Division of Hematology Products
`Office of Drug Evaluation 1
`Center for Drug Evaluation and Research
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`
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`ENCLOSURE:
` Content of Labeling
`
`o Prescribing Information
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`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4518170
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`
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ANN T FARRELL
`11/08/2019 04:43:44 PM
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`Reference ID: 4518170
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`