`
`
`
`
`
`
`
`
`( .I# I U.S. FOOD & DRUG
`
`,.,. .........
`•-..:::::i~
`
`ADMINISTRATION
`
`
`
`
` NDA 022249/S-025
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Cephalon, Inc. (a wholly owned subsidiary of Teva Pharmaceuticals Industries, Ltd.)
` Attention: Lisa Carle
`
`
` Director, Specialty Regulatory Affairs Labeling
`
`
` 145 Brandywine Parkway
`
`
`
`
` West Chester, PA 19380
`
`
`
` Dear Ms. Carle:
`
`
`
`
`
` Please refer to your supplemental new drug application (sNDA) dated
` December 14, 2020, received December 14, 2020, submitted under section 505(b) of
`
`
`
`
`
`
` the Federal Food, Drug, and Cosmetic Act (FDCA) for Treanda (bendamustine
`
` hydrochloride) injection.
`
` This Prior Approval supplemental new drug application provides safety-related labeling
`
`
`
`
`
`
` changes to include a new Warning and Precaution for progressive multifocal
` leukoencephalopathy (PML), addition of PML to Section 6.2 Postmarketing Experience
`
`
`
`
` and Section 17 Patient Counseling Information. In addition, there are proposed
` revisions to the existing warning for Other Malignancies to include non-melanoma skin
`
`
`
`
` cancer. There are few minor other editorial revisions throughout the label.
`
`
`
`
`
`
`
`
`
` APPROVAL & LABELING
`
`
`
`
`
`
`
`
`
` 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.
`
`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
`
`
`
`
`
`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
`
`in the enclosed labeling.
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`
`
`Reference ID: 4809355
`
`
`
`
`
`
`
`
` NDA 022249/S-025
` Page 2
`
`
`
`
`
`
` 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
`
`
`
`
`
`
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`
`
`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).
`
`
`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.
`
`
`
`
`
`Because none of these criteria apply to your application, you are exempt from this
`
`requirement.
`
`
`REPORTING REQUIREMENTS
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
` 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.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4809355
`
`
`
`
` NDA 022249/S-025
` Page 3
`
`
`
`
`
` If you have any questions, contact Denise Felluca, Regulatory Health Project Manager,
`
` at 301-796-4574.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Sincerely,
`
` {See appended electronic signature page}
`
` Shanthi Marur, MBBS, MD
`
`
`
`
`
` Associate Director for Safety (Acting)
` Office of Oncologic Diseases
`
`
`
` Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ENCLOSURE(S):
`
`• Content of Labeling
`
`
`
`o Prescribing Information
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4809355
`
`
`
`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/
`------------------------------------------------------------
`
`SHANTHI N MARUR
`06/10/2021 08:32:48 AM
`
`Reference ID: 4809355
`
`(
`
`
`
`