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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 18936/S-097/S-098
`NDA 21235/S-019/S-020
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Eli Lilly and Company
`Attention: Ashraff Rampersaud, M.S. PMP
`
`Manager, Global Regulatory Affairs – US
`Lilly Corporate Center
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`Indianapolis, IN 46285
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`
`Dear Mr. Rampersaud:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated March 30, 2012
`(18936/S-097 and 21235/S-019), and April 4, 2012 (18936/S-098 and 21235/S-020) submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Prozac
`(fluoxetine HCl) 10 mg, 20 mg, and 40 mg capsules (18936), and Prozac (fluoxetine HCl)
`delayed-release 90 mg capsules (21235).
`
`We acknowledge receipt of your amendments dated August 3, 2012, September 18, 2012, and
`December 19, 2012.
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`These supplemental new drug applications provide for the following changes to product labeling:
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`18936/S-097 and 21235/S-019 submitted as “Prior Approval”
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` Class labeling revisions to the Use in Specific Populations section regarding Pregnancy-
`Nonteratogenic Effects as requested in an Agency supplement request letter dated March 2,
`2012.
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`18936/S-098 and 21235/S-020 submitted as “Prior Approval”
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` Provides for class labeling revisions to the Dosage And Administration,
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`Contraindications, Warnings and Precautions, & Medication Guide regarding serotonin
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` toxicity associated with the co-administration of linezolid and methylene blue as requested in
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`an Agency supplement request letter dated March 5, 2012.
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`Reference ID: 3239279
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`

`

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` NDAs 18936/S-097/S-098& 21235/S-019/S-020
`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
`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.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`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 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, contact CDR Kofi Ansah, Pharm.D., Senior Regulatory Project
`Manager, at (301)796-4158 or email: Kofi.Ansah@fda.hhs.gov.
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`
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`Sincerely,
`
`{See appended electronic signature page}
`
`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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`ENCLOSURE: Content of Labeling
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`
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`Reference ID: 3239279
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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
`01/03/2013
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`Reference ID: 3239279
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`