NDA 205552/S-031
`
`NDA 210563/S-007
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Pharmacyclics LLC
`Attention: Preeti Sarde
`Manager, Regulatory Affairs
`999 East Arques Avenue
`Sunnyvale, CA 94085-4521
`
`
`
`Dear Ms. Sarde:
`
`Please refer to your supplemental new drug applications (sNDAs) dated
`February 14, 2020, received February 14, 2020, and your amendments, submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Imbruvica (ibrutinib) capsules and tablets.
`
`These Prior Approval supplemental new drug applications provide for revisions to the
`Full Prescribing Information (FPI) Section 6 Adverse Reactions: Sub Section 6.1 Clinical
`Trial Experience to add ischemic cerebrovascular events to the subsection
`Cardiovascular Events, and for revisions to Sub Section 6.2 Post Marketing Experience
`to add neutrophilic dermatoses.
`
`
`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.
`
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`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.
`
`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
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`Reference ID: 4653470
`
`

`

`NDA 205552/S-031
`NDA 210563/S-007
`Page 2
`
`
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
`
`in the enclosed labeling.
`
`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: 4653470
`
`

`

`NDA 205552/S-031
`NDA 210563/S-007
`Page 3
`
`
`If you have any questions, call Laura Wall, Senior Regulatory Project Manager, at
`
`(301) 796-2237.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Abhilasha Nair, MD
`Associate Director for Safety (acting)
`
`Office of Oncologic Diseases
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURES:
`
` Content of Labeling
`
`o Prescribing Information
`
`o Patient Package Insert
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4653470
`
`

`

`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/
`------------------------------------------------------------
`
`ABHILASHA NAIR
`08/07/2020 12:33:10 PM
`
`Reference ID: 4653470
`
`(
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