`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
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`21-372
`
`Correspondence
`
`
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`
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`3‘
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`0'
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`if ’6 DEPARTL‘IENTOFHEALTH&HUNIANSERVICES
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`r
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`PublicHealthService
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`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21-372
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`Helsinn Healthcare SA
`
`c/o August Consulting
`Attention: Craig Lehmann, Pharm.D.
`515 Capital ofTexas Highway, Suite 150
`Austin, TX 78746
`
`Dear Dr. Lehmann:
`
`/
`
`l/Lf/
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`O 2—\
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`We have received your new drug application (NDA) submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act for the following:
`
`Name of Drug Product:
`
`Palonosetron Hydrochloride Intravenous Injection, 0.25 mg
`
`. Review Priority Classification: (S) Standard
`
`Date oprplication: September 26, 2002
`
`Date of Receipt: September 27, 2002
`
`Our Reference Number: NDA 21-372
`
`Unless we notify you within 60 days of the receipt date that the application is not sufficiently
`complete to permit a substantive review, we will file the application on November 26, 2002 in
`accordance with 21 CFR 314.101(a). If we file the application, the user fee goal date will be
`July 27, 2003.
`
`Under 21 CFR 314.102(c), you may request an informal conference with this Division (to be
`held approximately 90 days from the above receipt date) for a brief report on the status of the
`review but not on the ultimate approvability of the application. Alternatively, you may choose to
`receive a report by telephone.
`
`Please cite the NDA number listed above at the top of the first page of any communications
`concerning this application. Address all communications concerning this NDA as follows:
`
`
`
`NDA 21-372
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`Page 2
`
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`US. Postal Service/Courier/Ovemiaht Mail:
`
`Center for Drug Evaluation and Research
`Division of Gastrointestinal and Coagulation Drug Products, HFD-180
`Attention: Division Document Room, 63-24
`5600 Fishers Lane
`
`Rockville, Maryland 20857
`
`Ifyou have any questions, call me at (301) 827-7310.
`
`Sincerely,
`
`{See tippinuIeCWnic signamrepage}
`
`Brian Strongin, R.Ph., M.B.A.
`Regulatory Health Project Manager
`Division of Gastrointestinal and
`
`Coagulation Drug Products
`Office of Drug Evaluation 111
`Center for Drug Evaluation and Research
`
`
`
`This'IS a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Brian Strongin
`11/7/02 01:16:40 PM
`
`
`
`' .6: DEPARTMENTOFHEALTH8: HUMANSERVICES
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`PublicHealthService
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`__—‘_—_—“
`
`Food and Drug Administration
`Rockville, MD 20857
`
`mi:
`
`Helsinn Healthcare SA
`
`Attention: Craig Lehmann (US Agent), PharmD.
`515 Capital ofTexas Hwy, Suite #150
`Austin, TX 78746
`
`Dear Dr. Lehmann:
`
`Please refer to the meeting between representatives of your firm and FDA on January 30, 2001.
`The purpose of the meeting was to discuss the production of drug product registration batches for
`Palonosetron Injection and initiation ofthe drug product stability program for those batches.
`
`The official minutes ofthat meeting are enclosed. You are responsible for notifying us ofany
`significant differences in understanding regarding the meeting outcomes.
`
`Ifyou have any questions, call me at (30]) 827-7310.
`
`Sincerely,
`
`[See "Mé’gw electronic signature page}
`
`Melodi McNeil
`
`Regulatory Health Project Manager
`Division ofGastrointestinal & Coagulation Drug
`Products
`
`Office of Drug Evaluation 1]]
`Center for Drug Evaluation and Research
`
`Enclosure
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`
`
`RedaCted 4/.
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`pages of trade
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`segrét and/or
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`‘confidential
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`commerCial. .'_"
`
`infOrmation
`
`
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