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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-006
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`Helsinn Healthcare SA
`Attn: Craig Lehmann, Pharm.D.
`US Agent, August Consulting
`515 Capital of Texas Highway, Suite #150
`Austin, TX 78746
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`Dear Dr. Lehmann:
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`Please refer to your supplemental new drug application dated July 31, 2006, received August 2, 2006,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Aloxi® (palonosetron
`hydrochloride) 0.25 mg/mL Injection, 5 mL.
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`We acknowledge receipt of your submissions dated September 14, 26, October 6, and
`December 18, 2006, May 23, and August 22, 2007.
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`This supplemental new drug application provides for a change in the dosage and administration
`section of the ALOXI labeling. You proposed to delete a sentence which prevents repeated dosing
`within a seven day interval.
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`We completed our review of this application, as amended and it is approved, effective on the date of
`this letter, for use as recommended in the agreed-upon labeling text and with the minor editorial
`revisions indicated in the enclosed labeling.
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`The following items are the minor and editorial changes made in the attached label:
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`•
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`"See full prescribing information for ALOXI" – a period was added to this sentence at the top
`of Highlights.
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`"See 17 for PATIENT COUNSELING INFORMATION and FDA-Approved patient labeling,"
`The words "Patient" and "Labeling" are now capitalized.
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`• A vertical line in the left margin was added to Section 2.1 in the FPI because it’s the Recent
`Major Change.
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`In 12.3 under Special Populations, the cross-reference to section 8 was corrected.
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`In section 17 in the FULL PRESCRIBING INFORMATION (FPI), under "17 PATIENT
`COUNSELING INFORMATION," a reference to 17.2 was added to read: "See FDA-approved
`Patient Labeling (17.2)."
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`•
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`•
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`NDA 21-372/S-006
`Page 2
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`Please make the following format corrections to your label:
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`• The "Use in Specific Populations" header in Highlights has an odd, incomplete dashed line.
`Please correct this and make it consistent with the others.
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`• You must add a vertical line at the bottom of page one separating the “CONTENTS” section
`from the FPI.
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`These revisions are terms of the approval of this application.
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`Within 21 days of the date of this letter, submit content of labeling [21 CFR 314.50(l)] in structured
`product labeling (SPL) format, as described at http://www.fda.gov/oc/datacouncil/spl.html, that is
`identical in content to the enclosed labeling text. Upon receipt and verification, we will transmit that
`version to the National Library of Medicine for public dissemination.
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`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are
`waiving the pediatric study requirement for this application.
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`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`the Division of Gastroenterology Products and two copies of both the promotional materials and the
`package inserts directly to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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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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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-372/S-006
`Page 3
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`If you have any questions, call Giuseppe Randazzo, Project Manager, at (301) 796-0980.
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`Sincerely,
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`{See appended electronic signature page}
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`Joyce Korvick, M.D., MPH
`Deputy Director
`Division of Gastroenterology Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`Enclosure (label)
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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
`8/30/2007 10:18:52 AM
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