`
`{ ~ lffll U.S. FOOD & DRUG
`
`\,.,,~~ -
`
`ADMINISTRATION
`
`
`NDA 210259/S-009
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
` AstraZeneca UK Limited
`
`
`
` Attention: Vanessa Yu, PhD
` Director, Regulatory Science
`
`
` 1 Medimmune Way
` Gaithersburg, MD 20878
`
`
`
`Dear Dr. Yu:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`
`March 21, 2022, submitted under section 505(b) of the Federal Food, Drug, and
`
`
`
`Cosmetic Act (FDCA) for Calquence (acalabrutinib) capsules.
`
`
`This “Changes Being Effected” sNDA provides for formatting changes to Table 2 in
`
`
`section 2.4 of the US Prescribing Information so as to provide clear adequate
`
`
`
`
`information regarding dose modifications for the safe and effective use of the drug.
`
`
`APPROVAL & LABELING
`
`
`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.
`
`
`
`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 (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. If the content of labeling in SPL format initially submitted with this
`
`CBE-0 labeling supplement is identical to the attached approved labeling, an additional
`
`
`submission of content of labeling in SPL format is not required.
`
`
`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
`
`
`
`
` 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.
`
`
`
`
`Reference ID: 4957324
`
`
`
`
`
`
`
`
`
` NDA 210259/S-009
`
` Page 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.
`
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`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
`
`
`
`
`
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4957324
`
`
`
`
`
`
`
` NDA 210259/S-009
`
` Page 3
`
`
`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, contact Denise Felluca, Regulatory Health Project Manager,
`
`at 301-796-8495.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Nicole J. Gormley, MD
`
`Director
`
`Division of Hematologic Malignancies II
`
`Office of Oncologic Diseases
`
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`ENCLOSURE:
`
`
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 4957324
`
`
`
`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/
`------------------------------------------------------------
`
`NICOLE J GORMLEY
`03/24/2022 10:36:41 AM
`
`Reference ID: 4957324
`
`(
`
`
`
`