DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`Rockville MD 20857
`
`NDA 21-411
`
`Eli Lilly and Company
`Attention: Robin P. Wojcieszek, R.Ph.
`Senior Regulatory Scientist
`Lilly Corporate Center
`Indianapolis, IN 46285
`
`Dear Ms.Wojcieszek:
`
`Please refer to your supplemental new drug application (NDA) dated December 11, 2002, received
`December 13, 2002, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`StratteraTM (atomoxetine hydrochloride) Capsules.
`
`This supplemental new drug application provides for a patient package insert (PPI) as part of the labeling.
`
`We refer to two facsimile communications dated December 13 and December 18, 2002, concerning the
`wording of the PPI labeling.
`
`We also refer to the January 16, 2003, telephone conversation between Ms. Robin Wojcieszek, Lilly Senior
`Regulatory Scientist, and Ms. Anna Marie H. Weikel, Senior Project Manager of this Division, during which
`the final PPI labeling was agreed upon.
`
`We have completed the review of this supplemental application, 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
`agreed upon enclosed PPI labeling text. Accordingly, the supplemental application is approved effective on
`the date of this letter.
`
`The final printed labeling (FPL) must be identical to the agreed upon enclosed labeling (text for the patient
`package insert). Marketing the product with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`Please submit the copies of final printed labeling (FPL) electronically according to the guidance for industry
`titled Providing Regulatory Submissions in Electronic Format - NDA (January 1999). Alternatively, you
`may submit 20 paper copies of the FPL as soon as it is available but no more than 30 days after it is printed.
`Please individually mount ten of the copies on heavy-weight paper or similar material. For administrative
`purposes, this submission should be designated "FPL for approved
`NDA 21-411/S-001." Approval of this submission by FDA is not required before the labeling is used.
`
`

`

`NDA 21-411/S-001
`Page 2
`
`If you should have any questions, please call Ms. Anna Marie H. Weikel, R.Ph., Senior Regulatory Project
`Manager, at (301) 594-5535.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, M.D.
`Director
`Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Enclosure
`
`

`

`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Russell Katz
`1/17/03 08:17:30 AM
`
`