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`Trade Name:
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`Generic Name:
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`Sponsor:
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`
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`Approval Date:
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`Indication:
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`Approval Package for:
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`APPLICATION NUMBER:
`
`206439Orig1s000
`
` Namzaric Capsules 14mg/10mg and 28mg/10mg.
`
`memantine hydrochloride extended-release/donepezil
`hydrochloride
`
`Forest Laboratories, Inc.
`
`December 23, 2014
`
`For the treatment of moderate to severe dementia of the
`Alzheimer’s type in patients stabilized on either of the
`following regimens:
`
`
` Memantine hydrochloride (10mg twice daily or 28
`mg extended-release once daily) and donepezil
`hydrochloride 10 mg.
` Memantine hydrochloride (5 mg twice daily or 14
`mg extended-release once daily) and donepezil
`hydrochloride 10 mg.
`
`
`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`206439Orig1s000
`
`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
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology / Virology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
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`X
`X
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`X
`X
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`X
`X
`X
`X
`X
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`X
`X
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`

`

`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`206439Orig1s000
`APPROVAL LETTER
`
`
`
`
`
`
`
`

`

`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`NDA 206439
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`February 27, 2014
`June 19, 2014
`November 21, 2014
`December 23, 2014
`
`
`
`
`
`
`June 10, 2014
`May 29, 2014
`September 3, 2014
`August 7, 2014
`December 8, 2014 December 19, 2014
`
`
`Forest Laboratories, Inc.
`Attention: Kathleen Waldron
`MBA, Senior Director, Regulatory Affairs
`Harborside Financial Center
`Plaza V, Suite 1900
`Jersey City, NJ 07311
`
`
`Dear Ms. Waldron:
`
`Please refer to your New Drug Application (NDA) dated February 26, 2014, received February
`26, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Namzaric (memantine hydrochloride extended-release/donepezil hydrochloride)
`Capsules 14mg/10mg and 28mg/10mg.
`
`We acknowledge receipt of your amendments dated:
`
`
`
`
`
`
`
`This new drug application provides for the use of for Namzaric (memantine hydrochloride
`extended-release/donepezil hydrochloride) Capsules 14mg/10mg and 28mg/10mg for the
`treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on either
`of the following regimens:
`
`
`• memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and
`donepezil hydrochloride 10 mg
`• memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and
`donepezil hydrochloride 10 mg
`
`
`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.
`
`
`
`
`Reference ID: 3678032
`
`

`

`NDA 206439
`Page 2
`
`
`WAIVER OF HIGHLIGHTS SECTION
`
`We acknowledge your request to waive the requirements of 21 CFR 201.57(d)(8) regarding the
`length of the Highlights of Prescribing Information section. As previously communicated to
`you, we are denying your request.
`
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, and text for the
`patient package insert). 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
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to the carton and
`immediate container labels submitted on December 23, 2014, as soon as they are available, but
`no more than 30 days after they are printed. Please submit these labels electronically according
`to the guidance for industry Providing Regulatory Submissions in Electronic Format – Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(June 2008). Alternatively, you may submit 12 paper copies, with 6 of the copies individually
`mounted on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “Final Printed Carton and Container Labels for approved NDA 206439.”
`Approval of this submission by FDA is not required before the labeling is used.
`
`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`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.
`
`We are waiving the pediatric study(ies) requirement for this application because dementia of the
`Alzheimer’s type does not occur in children and the necessary studies are, therefore, impossible.
`
`
`Reference ID: 3678032
`
`

`

`NDA 206439
`Page 3
`
`
`PROMOTIONAL MATERIALS
`
`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
`to:
`
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`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.
`
`
`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, call Teresa Wheelous, Sr. Regulatory Project Manager, at (301) 796-
`1161.
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Billy Dunn, MD
`Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Enclosure(s):
`Content of Labeling – PI & PPI
`
`
`
`Reference ID: 3678032
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`WILLIAM H Dunn
`12/23/2014
`
`Reference ID: 3678032
`
`