`NDA202324/S-10
`
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
` PF Prism C.V.
` c/o Pfizer Manufacturing Holdings LLC
`
` Attention: Melissa J. McMahon, MS
`
` Sr. Manager, Pfizer Global Regulatory Affairs
` 235 East 42nd Street
`
`
` New York, NY 10017-5755
`
`
`
`
`Dear Ms. McMahon:
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received July
`
`
`
`16, 2019, and your amendments, dated December 23, 2019, January 7, 2020, January
`
`
`
`
`
`16, 2020, and January 22, 2020, submitted under section 505(b) of the Federal Food,
`
`
`
`Drug, and Cosmetic Act (FDCA) for Inlyta (axitinib) tablets.
`
`
`
`
`
`
`
`This Prior Approval supplemental new drug application provides for updates to the
`
`
`
`Warnings and Precaution subsection (5.8): Risk of Impaired Wound Healing; updates to
`
`Patient Counseling Information (17) and the Patient Information labeling for consistency
`
`with the updates to subsection 5.8; revisions to the Adverse Reactions (6) and the Drug
`
`
`
`
`Interactions (7) sections and the Use in Specific Populations subsection (8.4): Pediatric
`
`Use and Clinical Pharmacology subsection (12.3): Pharmacokinetics to conform with
`
`
`
`
`applicable regulations and guidances for product labeling; and editorial changes.
`
`
`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, with minor editorial revisions listed below and reflected in the enclosed
`
`labeling.
`
`
`
`
`
`
`
`
`
`
`• Highlights of Prescribing Information subsection Recent Major Changes and end
`
`
`of Highlights revised to include the date of Recent Major Changes and
`
`
`Prescribing Information last updated as “1/2020”.
`
`
`
`• Patient Package Insert revised to include date of last revision as “Revised:
`
`January 2020”.
`
`
`
`Reference ID: 4548523
`
`

`

`
`
`
` NDA 202324/S-10
` Page 2
`
`
`
` 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 and Patient Package Insert), 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.
`
`
`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.
`
`
`PROMOTIONAL MATERIALS
`
`
`
`
`All promotional materials that include representations about your drug product must be
`
`promptly revised to be consistent with the labeling changes approved in this
`
`
`
`
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`
`
`
` 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.
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`
`
`
`
`Reference ID: 4548523
`
`

`

`
` NDA 202324/S-10
` Page 3
`
`
`
` in your promotional materials should include prominent disclosure of the important new
`
`
`
`
`
` safety information that appears in the revised labeling. Within 7 days of receipt of this
` letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4) to the
`
`
`
`
`
`
`
` address above, by fax to 301-847-8444, or 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
`
`
` Prescription Drugs.
`
` 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 you may contact Felicia Diggs, Senior Regulatory Project
`
`
`Manager, at (240) 402-4932 or via email at Felicia.diggs@fda.hhs.gov.
`
`
`
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Patricia Keegan, M.D.
`
`Acting Associate Director for Medical Policy
`
`
`Oncology Center for Excellence
`
`
`U.S. Food & Drug Administration
`
`
`
`
`
`
`
`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: 4548523
`
`

`

`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/
`------------------------------------------------------------
`
`PATRICIA KEEGAN
`01/23/2020 09:08:06 AM
`
`Reference ID: 4548523
`
`(
`
`
`
`