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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22567/S-009
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`POSTMARKETING COMMITMENT FULFILLED
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` Forest Laboratories, Inc.
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`Attention: Kaity Posada, Pharm.D
`Director, Regulatory Affairs
`Harborside Financial Center, Plaza V
`Jersey City, NJ 07311
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`Dear Dr. Posada:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received on January
`31, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Viibryd (vilazodone hydrochloride) 10 mg, 20 mg, and 40 mg tablets.
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`We acknowledge receipt of your amendments dated October 30, 2013 and December 9, 2013.
`We also refer you to the Approval letter dated January 21, 2011.
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`This “Prior Approval” supplemental new drug application contains final study reports and
`proposes labeling modifications based upon findings from the following postmarketing
`commitments (PMC’s 1723-9 and 1723-10) as prescribed in the January 21, 2011 Approval
`letter.
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`1723-9
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`Vilazodone is metabolized primarily by CYP3A4. You have not submitted
`information on the potential effect of CYP3A4 induction on vilazodone exposure.
`We request that you conduct a drug-drug interaction trial of vilazodone using a
`CYP3A4 inducer (carbamazepine) in healthy subjects.
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`1723-10
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`Vilazodone is extensively metabolized; however, the pharmacokinetics of
`vilazodone in patients with severe hepatic impairment has not been assessed. We
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`request that you conduct a Phase 1 trial to evaluate the pharmacokinetics of
`vilazodone in patients with severe hepatic impairment.
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`We have completed our review of this supplemental application, as amended, and conclude that
`the above commitments have been fulfilled. Therefore, it is approved, effective on the date of
`this letter, for use as recommended in the enclosed, agreed-upon labeling text. We remind you
`that there are postmarketing requirements and postmarketing commitments listed in the January
`21, 2011 approval letter that are still open.
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`Reference ID: 3423268
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`NDA 22567/S-009
`Page 2
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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
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`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), 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.
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`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 includes 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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`If you have any questions, call Bill Bender, Senior Regulatory Project Manager, at (301) 796-
`2145.
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`Sincerely,
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`{See appended electronic signature page}
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`Mitchell V. Mathis, M.D.
`CAPT, USPHS
`Director (acting)
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Reference ID: 3423268
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`NDA 22567/S-009
`Page 3
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 3423268
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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
`12/17/2013
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`Reference ID: 3423268
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