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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 020822/S-047
`NDA 021323/S-047
`NDA 021365/S-035
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`NDA 022567/S-020
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Forest Laboratories, Inc.
`
`Attention: Nadia Success
`Manager Regulatory Affairs
`Harborside Financial Center
`Plaza V, Suite 1900
`
`Jersey City, NJ 07311
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`Dear Ms. Success:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated October 21, 2016,
`received October 21, 2016, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Celexa (citalopram) 10 mg, 20 mg, and 40 mg tablets (NDA 020822);
`Lexapro (escitalopram oxalate), 5 mg, 10 mg, and 20 mg tablets (NDA 021323); Lexapro
`(escitalopram oxalate), 5 mg base/5 ml oral solution (NDA 021365); Viibryd (vilazodone
`hydrochloride) 10 mg, 20 mg,40 mg Tablets (NDA 022567).
`
`We also refer to our letter dated September 21, 2016, notifying you, under Section 505(o)(4) of
`the FDCA, of new safety information that we believe should be included in the labeling for all
`selective serotonin reuptake inhibitor (SSRI) and serotonin and norepinephrine reuptake inhibitor
`(SNRI) products. This information pertains to the addition of “amphetamine” to list of
`serotonergic drugs which can potentially increase risk for serotonin syndrome.
`
`These supplemental new drug applications provide for revisions to the labeling for Celexa,
`Lexapro, and Viibryd consistent with our September 21, 2016 letter.
`
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`
`We note that your October 21, 2016, submission includes final printed labeling (FPL) for your
`package insert, and Medication Guide. We have not reviewed this FPL. You are responsible for
`assuring that the wording in this printed labeling is identical to that of the approved content of
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`labeling in the structured product labeling (SPL) format.
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`Reference ID: 4036381
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`NDA 020822/S-047
`NDA 021323/S-047
`NDA 021365/S-035
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`NDA 022567/S-020
`Page 2
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`WAIVER OF HIGHLIGHTS SECTION
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of prescribing information.
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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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert, Medication Guide), with the addition of any labeling changes in pending
`“Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
`included in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible from publicly available labeling repositories.
`
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`Also within 14 days, amend all pending supplemental applications that include labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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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: 4036381
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`
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`NDA 020822/S-047
`NDA 021323/S-047
`NDA 021365/S-035
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`NDA 022567/S-020
`Page 3
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`If you have any questions, contact CAPT Bill Bender, Senior Regulatory Project Manager, at
`(301) 796-2145 william.bender@fda.hhs.gov.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Mitchell V. Mathis, MD
`Division Director
`Division of Psychiatry
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
`
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`Reference ID: 4036381
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`
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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/
`----------------------------------------------------
`
`MITCHELL V Mathis
`01/04/2017
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`Reference ID: 4036381
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`