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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-005
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`Helsinn Healthcare SA
`Attention: Timothy K Ressler, (US Agent, MGI Pharma, Inc.)
`Vice President, Regulatory Affairs
`6611 Tributary St
`Baltimore, MD 21224
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`Dear Mr. Ressler:
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`Please refer to your supplemental new drug application dated February 16, 2006, received
`February 23, 2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`for Aloxi® (palonosetron hydrochloride) Injection, 0.25 mg/mL, 5 mL.
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`This “Changes Being Effected” supplemental new drug application provides to add a statement to the
`ADVERSE REACTIONS Section of the Package Insert (PI).
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`We completed our review of this application. 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 package insert
`submitted February 16, 2006.
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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, Regulatory Project Manager, at (301) 796-0991.
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`Enclosure
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`Sincerely,
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`{See appended electronic signature page}
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`Joyce Korvick, M.D., M.P.H.
`Deputy Director
`Division of Gastroenterology Products
`Office of Drug Evaluation III
`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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`Joyce Korvick
`8/23/2006 12:59:14 PM
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