CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICATION NUMBER:
`213801Orig1s000
`
`
`Trade Name:
`
`MYRBETRIQ GRANULES, for extended-release
`oral suspension
`
`Generic or Proper
`Name:
`
`Sponsor:
`Approval Date:
`
`Indication:
`
`mirabegron
`
`Astellas Pharma Global Development, Inc.
`March 25, 2021
`treatment of neurogenic detrusor overactivity (NDO)
`in pediatric patients aged 3 years and older
`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`213801Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
`
`X
`X
`
`
`X
`X
`X
`X
`
`X
`X
`
`X
`X
`
`

`

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`
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`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`213801Orig1s000
`
`
`APPROVAL LETTER
`
`

`

`NDA 213801
`
`Astellas Pharma Global Development, Inc.
`Attention: Carol Soo
`Director, Regulatory Affairs
`1 Astellas Way
`Northbrook, IL 60062
`
`Dear Ms. Soo:
`
`NDA APPROVAL
`
`Please refer to your new drug application (NDA) dated and received
`September 28, 2020, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Myrbetriq Granules (mirabegron
`extended-release for oral suspension), 8 mg/mL.
`
`This new drug application provides for the use of Myrbetriq Granules (mirabegron for
`extended-release oral suspension), 8 mg/mL, for the treatment of neurogenic detrusor
`overactivity (NDO) in pediatric patients aged 3 years and older.
`
`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
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
`Highlights of Prescribing Information. This waiver applies to all future supplements
`containing revised labeling unless we notify you otherwise.
`
`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, as well as annual reportable
`changes not included in the enclosed labeling. Information on submitting SPL files using
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 4768327
`
`

`

`NDA 213801
`Page 2
`
`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 via publicly available labeling repositories.
`
`CARTON AND CONTAINER LABELING
`
`Submit final printed carton and container labeling that are identical to the enclosed
`carton and container labeling, as soon as they are available, but no more than 30 days
`after they are printed. Please submit these labeling electronically according to the
`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
`Carton and Container Labeling for approved NDA 213801.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`DATING PERIOD
`Based on the stability data submitted to date, the expiry dating period for Myrbetriq
`Granules (mirabegron extended-release for oral suspension) shall be 24 months from
`the date of manufacture when stored at 20°C to 25ºC.
`
`Results of ongoing stability should be submitted throughout the dating period in your
`annual report, as they become available, including the results of stability studies from
`the first three production lots.
`
`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.
`
`This product is appropriately labeled for use in all relevant pediatric populations.
`Therefore, no additional pediatric studies are needed at this time.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`
`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: 4768327
`
`

`

`NDA 213801
`Page 3
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format—Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
`and the Prescribing Information, at the time of initial dissemination or publication,
`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
`Information and Instructions for completing the form can be found at FDA.gov.5
`
`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, please call Nenita Crisostomo, Regulatory Health Project
`Manager, at 301-796-0875.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Christine P. Nguyen, M.D.
`Director
`Division of Urology, Obstetrics, and
`Gynecology
`Office of Rare Diseases, Pediatrics, Urologic
`and Reproductive Medicine
`Center for Drug Evaluation and Research
`
`ENCLOSURES:
`(cid:120) Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`(cid:120) Carton and Container Labeling
`
`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: 4768327
`
`

`

`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/
`------------------------------------------------------------
`
`CHRISTINE P NGUYEN
`03/25/2021 03:52:26 PM
`
`Reference ID: 4768327
`
`(
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