`·.·:.·_ · __ ··:...._
`
`~· . ' :.
`
`·-.:.:...
`
`····.---
`
`._ .. ~:· ' .. ·
`
`Robert L. Justice, MD, Director
`Division of Gastrointestinal and Coagulation Drug Products
`HFD-180
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
`
`Pazzallo, September 26, 2002
`DCE/lbal
`
`Re: NDA 21-372
`Palonosetron Hydrochloride Intravenous Injection, 0.25 mg
`Original Submission
`
`Dear Dr. Justice:
`
`In accordance with 21 CFR 314.50, we are pleased to submit this original New Drug
`Application for Palonosetron Hydrochloride Intravenous Injection, 0.25 mg, for the
`prevention of acute and delayed nausea and vomiting associated with initial and repeated
`courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy.
`
`FDA acknowledged receipt of the user fee for this NDA on September 16, 2002. The
`user fee identification number is 4391.
`
`As agreed during the pre-NDA meeting and in subsequent communications, the entire
`NDA is submitted in hard copy with the exception of Section 11, Case Report
`Tabulations, which is submitted electronically in the archival copy. To facilitate review,
`the following electronic files on compact disks (CDs) are attached.
`
`• Proposed labeling in Word 97 (CD #1)
`• NDA Summary, Section 3.0, in Word 97 (CD #1)
`• Case Report Tabulations (PDF files), Section 11.0 (CD #2; CD #3)
`•
`ISS database, SAS transport version 5 files (CD #4)
`•
`ISE database, SAS transport version 5 files (CD #4)
`• Rat (P AL0-98-03) carcinogenicity study datafiles (CD #5)
`• Mouse (P AL0-99-18) carcinogenicity study datafiles (CD #6)
`• Drug product stability data, including SAS transport version 5 files (CD #7)
`
`I FINAL NDACoverLetter 20Seot02
`
`l/2
`
`HIGHLY CONFIDENTIAL- OUTSIDE COUNSEL EYES ONLY
`
`HE LS N 0003536
`
`PTX-321.0009
`
`Helsinn Healthcare Exhibit 2053
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 2
`
`
`
`Both drug substance and drug product manufacturing establishments are ready for pre(cid:173)
`approval inspection at this time as described in the establishment information attached to
`the Form FDA 356h.
`
`Consistent with discussion at the pre-NDA meeting, 18-month drug product stability data
`from the RP Scherer West, Inc., dba SP Pharmaceuticals manufacturing site is planned
`for submission during review in the March 2003 timeframe.
`
`A letter appointing Dr. Craig Lehmann, August Consulting, as Authorized Representative
`for this NDA is attached to this cover letter. Dr. Lehmann is also cited on the Form FDA
`356h in this capacity. Please contact him at 512-347-1755, fax 512-34 7-9375, regarding
`all matters pertaining to this NDA.
`
`Patent information is also attached in this letter.
`
`Please contact me at our corporate headquarters in Lugano, Switzerland, ifi can be of
`assistance. My phone number is 011-41-91-985-2121.
`
`Sincerely,
`
`HELSINN HEALTHCARE SA
`
`j)~~·
`
`Dario Ceriani, M. Chern. Phann.
`Senior Manager Regulatory Affairs
`
`Cy:
`
`Dr. Craig Lehmann Authorized Representative for the NDA (August Consulting)
`Mr. Franco DeVecchi Sr., Authorized US Corporate Representative (VPCI Inc.)
`
`Atch.: Letter appointing Dr. Lehmann as Authorized Representative for the NDA
`Electronic files on CD with inventory (Archival copy only)
`Patent Information
`
`I FrNAL NDACoverLetter 20Seot02
`
`2/2
`
`HIGHLY CONFIDENTIAL- OUTSIDE COUNSEL EYES ONLY
`
`HELSN0003537
`
`PTX-321.0010
`
`Page 2 of 2
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