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`Astellas Pharma Global Development, Inc.
`Attention: Carol Soo
`Director, Regulatory Affairs
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`1 Astellas Way
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`Northbrook, IL 60062
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`Dear Ms. Soo:
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` NDA APPROVAL
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`Please refer to your new drug application (NDA) dated and received
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`September 28, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Myrbetriq Granules (mirabegron
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`extended-release for oral suspension), 8 mg/mL.
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`This new drug application provides for the use of Myrbetriq Granules (mirabegron for
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`extended-release oral suspension), 8 mg/mL, for the treatment of neurogenic detrusor
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`overactivity (NDO) in pediatric patients aged 3 years and older.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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`Highlights of Prescribing Information. This waiver applies to all future supplements
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`containing revised labeling unless we notify you otherwise.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Patient Package Insert, as well as annual reportable
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`changes not included in the enclosed labeling. Information on submitting SPL files using
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4768327
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`NDA 213801
`Page 2
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`eLIST may be found in the guidance for industry SPL Standard for Content of Labeling
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`Technical Qs and As.2
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`The SPL will be accessible via publicly available labeling repositories.
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed
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`carton and container labeling, as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labeling electronically according to the
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`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications. For administrative purposes, designate this submission “Final Printed
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`Carton and Container Labeling for approved NDA 213801.” Approval of this
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`submission by FDA is not required before the labeling is used.
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`DATING PERIOD
`Based on the stability data submitted to date, the expiry dating period for Myrbetriq
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`Granules (mirabegron extended-release for oral suspension) shall be 24 months from
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`the date of manufacture when stored at 20°C to 25ºC.
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`Results of ongoing stability should be submitted throughout the dating period in your
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`annual report, as they become available, including the results of stability studies from
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`the first three production lots.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`This product is appropriately labeled for use in all relevant pediatric populations.
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`Therefore, no additional pediatric studies are needed at this time.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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` 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.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4768327
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`NDA 213801
`Page 3
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format—Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
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`and the Prescribing Information, at the time of initial dissemination or publication,
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`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and Instructions for completing the form can be found at FDA.gov.5
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, please call Nenita Crisostomo, Regulatory Health Project
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`Manager, at 301-796-0875.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Christine P. Nguyen, M.D.
`Director
`Division of Urology, Obstetrics, and
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`Gynecology
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`Office of Rare Diseases, Pediatrics, Urologic
`and Reproductive Medicine
`Center for Drug Evaluation and Research
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`ENCLOSURES:
`x Content of Labeling
`o Prescribing Information
`o Patient Package Insert
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`x Carton and Container Labeling
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
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`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
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`
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`Reference ID: 4768327
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`
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`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
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`Reference ID: 4768327
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`(
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