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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022063
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
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`Shire Development, LLC.
`Attention: Peggy Sung
`Manager, Global Regulatory Affairs
`300 Shire Way,
`Lexington, MA 02421
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`Dear Ms. Sung:
`
`Please refer to your New Drug Application (NDA) dated July 21, 2006, received July 21, 2006,
`and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Mydayis (mixed salts of a single-entity amphetamine product) extended-release
`capsules 12.5 mg, 25 mg, 37.5 mg, and 50 mg.
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`We acknowledge receipt of your amendment dated December 20, 2016, which constituted a
`complete response to our May 18, 2007, action letter.
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`This new drug application provides for the use of Mydayis (mixed salts of a single-entity
`amphetamine product) extended-release capsules for the treatment of Attention Deficit
`Hyperactivity Disorder (ADHD).
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`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 text.
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`WAIVER OF HIGHLIGHTS SECTION
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`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.
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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 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. Content of labeling
`must be identical to the enclosed labeling (text for the package insert and Medication Guide).
`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, available at
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`Reference ID: 4114154
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`NDA 022063
`Page 2
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible via publicly available labeling repositories.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your June 20, 2017, submission containing final printed carton and container
`labels.
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`MARKET PACKAGE
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`Please submit one market package of the drug product when it is available to the following
`address:
`
`
`Latrice Wilson, PharmD
`Food and Drug Administration
`Center for Drug Evaluation and Research
`White Oak Building 22, Room: 4111
`10903 New Hampshire Avenue
`Silver Spring, Maryland
`Use zip code 20903 if shipping via United States Postal Service (USPS).
`Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL, FedEx).
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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 new
`active ingredients, 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(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`We are waiving the pediatric study requirement for ages 0 to 3 years because necessary studies
`are impossible or highly impracticable. This is because the diagnostic criteria and assessment
`measures for determining efficacy for the treatment of ADHD in children less than 4 years old
`are not well defined, and pharmaceutical treatment in this age group is uncommon.
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`We are deferring submission of your pediatric studies for ages 4 to 5 years for this application
`because this product is ready for approval for use in adults and the pediatric studies have not
`been completed.
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`Your deferred pediatric studies required by section 505B(a) of the Federal Food, Drug, and
`Cosmetic Act are required postmarketing studies. The status of these postmarketing studies must
`be reported annually according to 21 CFR 314.81 and section 505B(a)(3)(C) of the Federal Food,
`Drug, and Cosmetic Act. These required studies are listed below.
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`Reference ID: 4114154
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`NDA 022063
`Page 3
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`3224-1 A single-dose, open-label, randomized pharmacokinetic study of MYDAYIS
`(mixed salts of a single-entity amphetamine product) extended-release in male
`and female children (4 to less than 6 years of age) with ADHD.
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`
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`Final Protocol Submission: 09/01/2017
`Study/Trial Completion:
`12/31/2018
`Final Report Submission:
`06/30/2019
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`3224-2 A 4-week randomized, double-blind, placebo-controlled, fixed -dose study of
`MYDAYIS (mixed salts of a single-entity amphetamine product) extended-
`release 6.25 mg in 4 to 5 year olds diagnosed with ADHD.
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`Final Protocol Submission: 09/01/2017
`Study/Trial Completion:
`12/31/2018
`Final Report Submission:
`06/30/2019
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`3224-3
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`Because of adverse reactions identified during your development program, it is
`not apparent from the studies you have conducted in 6 to 12 year old patients with
`ADHD that the lowest effective dose of MYDAYIS (mixed salts of a single-entity
`amphetamine product) extended-release has been identified. Conduct a 4-week
`randomized, double-blind, placebo-controlled, dose optimization study of
`MYDAYIS (mixed salts of a single-entity amphetamine product) extended-
`release 6.25 mg and 12.5 mg in 6 to 12 year olds diagnosed with ADHD.
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`Final Protocol Submission: 09/01/2017
`Study/Trial Completion:
`12/31/2018
`Final Report Submission:
`06/30/2019
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`3224-4 A one year Pediatric Open-Label Safety Study for patients age 4 to 12 years (at
`the time of entry into PMR 3224-1, PMR 3224-2, or PMR 3224-3) with ADHD.
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`Final Protocol Submission: 09/01/2018
`Study/Trial Completion:
`12/31/2019
`Final Report Submission:
`06/30/2020
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`Submit the protocols to your IND 066329, with a cross-reference letter to this NDA.
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`Reports of these required pediatric postmarketing studies must be submitted as a new drug
`application (NDA) or as a supplement to your approved NDA with the proposed labeling
`changes you believe are warranted based on the data derived from these studies. When
`submitting the reports, please clearly mark your submission "SUBMISSION OF REQUIRED
`PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of
`the submission.
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`Reference ID: 4114154
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`NDA 022063
`Page 4
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert,
`Medication Guide, and patient PI (as applicable) to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`Reference ID: 4114154
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`NDA 022063
`Page 5
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`If you have any questions, contact Latrice Wilson, PharmD, Regulatory Project Manager, at
`latrice.wilson@fda.hhs.gov or (240) 402-5317.
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`Sincerely,
`
`{See appended electronic signature page}
`
`Mitchell Mathis, MD
`Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Enclosures:
`Content of Labeling
`Carton and Container Labeling
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`
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`Reference ID: 4114154
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`MITCHELL V Mathis
`06/20/2017
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`Reference ID: 4114154
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