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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 206439
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`Food and Drug Administration
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` Silver Spring MD 20993
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` NDA APPROVAL
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`February 27, 2014
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`June 19, 2014
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`November 21, 2014
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`December 23, 2014
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`June 10, 2014
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`May 29, 2014
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`September 3, 2014
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`August 7, 2014
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`December 8, 2014 December 19, 2014
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`Forest Laboratories, Inc.
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`Attention: Kathleen Waldron
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`MBA, Senior Director, Regulatory Affairs
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`Harborside Financial Center
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`Plaza V, Suite 1900
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`Jersey City, NJ 07311
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`Dear Ms. Waldron:
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`Please refer to your New Drug Application (NDA) dated February 26, 2014, received February
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`26, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Namzaric (memantine hydrochloride extended-release/donepezil hydrochloride)
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`Capsules 14mg/10mg and 28mg/10mg.
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`We acknowledge receipt of your amendments dated:
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` 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
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` treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on either
` of the following regimens:
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` • memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and
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` donepezil hydrochloride 10 mg
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` • memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and
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` donepezil hydrochloride 10 mg
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`We have completed our review of this application, as amended. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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`Reference ID: 3678032
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` NDA 206439
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` Page 2
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` WAIVER OF HIGHLIGHTS SECTION
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`We acknowledge your request to waive the requirements of 21 CFR 201.57(d)(8) regarding the
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`length of the Highlights of Prescribing Information section. As previously communicated to
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`you, we are denying your request.
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`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
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`patient package insert). Information on submitting SPL files using eLIST may be found in the
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`guidance for industry SPL Standard for Content of Labeling Technical Qs and As, available at
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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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`Submit final printed carton and immediate container labels that are identical to the carton and
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`immediate container labels submitted on December 23, 2014, as soon as they are available, but
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`no more than 30 days after they are printed. Please submit these labels electronically according
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`to the guidance for industry Providing Regulatory Submissions in Electronic Format – Human
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`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
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`mounted on heavy-weight paper or similar material. For administrative purposes, designate this
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`submission “Final Printed Carton and Container Labels for approved NDA 206439.”
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`Approval of this submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
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`the product misbranded and an unapproved new drug.
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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
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`We are waiving the pediatric study(ies) requirement for this application because dementia of the
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`Alzheimer’s type does not occur in children and the necessary studies are, therefore, impossible.
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`Reference ID: 3678032
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` NDA 206439
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` Page 3
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
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`proposed materials in draft or mock-up form with annotated references, and the package insert
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`to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
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`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
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`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
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`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
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Teresa Wheelous, Sr. Regulatory Project Manager, at (301) 796­
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`1161.
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`Sincerely,
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` {See appended electronic signature page}
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` Billy Dunn, MD
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` Director
` Division of Neurology Products
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` Office of Drug Evaluation I
` Center for Drug Evaluation and Research
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` Enclosure(s):
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` Content of Labeling – PI & PPI
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`Reference ID: 3678032
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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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`WILLIAM H Dunn
`12/23/2014
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`Reference ID: 3678032
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