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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDAs 18-936/S-072, 20-101/S-033, 20-974/S-006, 21-235/S-004
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`Eli Lilly and Company
`Attention: Gregory T. Brophy, Ph.D.
`Lilly Corporate Center
`Indianapolis, IN 46285-2643
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`Dear Dr. Brophy:
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`Please refer to your supplemental new drug applications dated November 15, 2004, and received
`November 16, 2004, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Prozac and Sarafem (fluoxetine hydrochloride) pulvules (NDA 18-936), Prozac solution (NDA 20-
`101), Prozac tablets (NDA 20-974), and Prozac Delayed-Release Capsules (NDA 21-235).
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`We additionally refer to an Agency approvable letter dated January 12, 2005 as well as a letter dated
`January 26, 2005 clarifying our requested revisions to the labeling for the above supplemental
`applications.
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`We acknowledge receipt of your submissions dated February 4, 2005, providing for a complete
`response to our January 12, and 26, 2005 Agency letters.
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`These supplements provide for the addition of a boxed warning and other changes to product labeling
`and the addition of a Medication Guide pertaining to pediatric suicidality.
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`We have completed the review of these supplemental applications and have concluded that adequate
`information has been presented to demonstrate that the drug product is safe and effective for use as
`recommended in the submitted final printed labeling (package insert submitted February 4, 2005),
`which incorporates all of the revisions listed. Accordingly, these supplemental applications are
`approved effective on the date of this letter.
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`Since we have developed standardized labeling for all antidepressants used in children because of
`safety concerns associated with the use of these products in children, final printed labeling should be
`available on your WEB page within two weeks of the date of this letter, and on all products within 30
`days. Failure to make these changes within the specified period of time could make your product
`misbranded under 21 USC 321(n) and 352(a).
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`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
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`NDAs 18-936/S-072, 20-101/S-033, 20-974/S-006, & 21-235/S-004
`Page 2
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`If you have any questions, call Paul David, R.Ph., Senior Regulatory Project Manager, at (301)
`594-5530.
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`Sincerely,
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`{See appended electronic signature page}
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`Russell Katz, M.D.
`Director
`Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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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.
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` /s/
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`Russell Katz
`2/18/05 04:54:57 PM
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