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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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`NDA 21-372/S-002
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`Helsinn Healthcare SA.
`Attention: Ms. Carol Anding – (US Agent-MGI Pharma, Inc.)
`5775 West Old Shakopee Road, Suite 1000
`Bloomington, MN 55437
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`Dear Ms. Anding:
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`Please refer to your supplemental new drug application dated April 14, 2004, received April 16, 2004,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Aloxi™
`(palonosetron hydrochloride) Injection, 0.25 mg/5 mL.
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`We acknowledge receipt of your submissions dated January 5, January 31, and June 24, 2005.
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`We also acknowledge the June 28, 2005 teleconference between you and the Division and your June
`28, 2005 submission containing the agreed-upon final Patient Package Insert (PPI) text incorporating
`the agreed upon changes in your June 24, 2005 submission, and the additional revision discussed in the
`June 28, 2005 teleconference.
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`Your submission of January 5, 2005 constituted a complete response to our October 15, 2004 action
`letter.
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`This supplemental new drug application provides for the addition of a PPI to the labeling.
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`We completed our review of this application, as amended. This application is approved, effective on
`the date of this letter, for use as recommended in the agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed labeling text for the draft patient
`package insert (identified as “28 JUNE 2005 FINAL VERSION”), submitted June 28, 2005.
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. 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. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`Submission "FPL for approved supplement NDA 21-372/S-002. Approval of this submission by
`FDA is not required before the labeling is used.
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`NDA 21-372/S-002
`Page 2
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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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 Betsy Scroggs, Pharm.D., Regulatory Project Manager, at
`(301) 827-1250.
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`MEDWATCH, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
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`Sincerely,
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`{See appended electronic signature page}
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`Brian E. Harvey, M.D., Ph.D.
`Director
`Division of Gastrointestinal and Coagulation Drug Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`Enclosure:
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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/
`---------------------
`Joyce Korvick
`7/5/05 04:55:37 PM
`for Dr. Brian E Harvey
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