`
`RESEARCH
`
`. APPLICATION NUMBER:
`
`.21-372/8008/8010
`
`CHEMISTRY REVIEW; S!
`
`
`
`NDA 20-372/SE1-008
`
`010
`
`Page 1 of6
`
`Chemist Review: # 1
`
`1. Division: ONDQA Div.
`IV, Branch VIII
`
`2. NDA Number 21—372
`
`3. Name and Address of Applicant:
`Helsinn Healthcare SA
`G915 Pambio-Noranco
`
`Lugano, Switzerland
`
`. 4. Supplement(s):
`Number: SEl-00§
`Date(s): April 27t , 2008
`
`5. Name of Drug:
`6. Nonproprietary name:
`
`Aloxi (palonosetronOHCl) Injection
`Palonosetron injection
`
`7. Supplement Provides new efficicacy claim of prevention of post—
`operative
`(b) (4)1ausea and vomiting up to
`(b) (4)
`(b) (4)and to provide a new package presentation (0.075 mg/ 1.5 mL
`
`in a 2-mL vial)
`
`8. Amendment(s):
`
`10. How Dispensed:
`9. Pharmacological Category:
`Rx
`Treatment of CINV and PONV
`
`
`11. Related Documents:
`NA
`
`12. Dosage Form: I.V. injection
`
`13. Potency: 0.05 mg/mL
`
`‘- xJ): 19.13.
`
`14. Chemical Name and Structure: palonosetronOHCI
`
`meager. Chemically, paienesetrou hydrochforitle its: {SAflE-ififl —
`Azanicyeilo Q.2.2]oct~3-y1]—2,3.3213,5:6-31exahytim-i—axe-
`lflbenzkieéisoqeifloline hyda’echlm‘ide. The amid-cal formula is
`CHI-LaugizGI-ICL with a moieculm weight. of 3313?. ‘Paienosetmn
`lg’dmchlmide exists as a single isomer and has the following sanctum!
`fommla:
`
`I?
`. J“M
`
`.
`
`
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`
`
`
`
`The original NDA provided for a 0.25 mg/5 mL dose (5 mL of a 0.05 mg/mL solution in a 5-mL glass vial
`sealed
`(b) (4)This efficacy supplement proposes a 0.075 mg/ 1.5 mL dose (1.5 mL of a 0.05
`mg/mL solution filled into a 2-mL glass vial
`
`Page 2 of6
`(b) (4)010
`NDA 20-372/SE1-008,
`(b) (4)010 were linked together for purpose of review. The CMC
`15. Comments: NDA 2l-372/S-008,
`
`
`
`review will be attached to NDA 21—372/512'1-008, which proposes a new efficacy claim, namely the treatment of
`post-operative nausea and vomiting (PONV). The original NDA 21-372 was approved for use in the treatment
`
`
`of chemotherapy-induced nausea and vomiting (CINV). A CMC review is required for this supplement because
`the applicant is also proposing a new package presentation, designed to deliver a smaller dose for the PONV
`
`indication.
`
`
`(b) (4)
`
`
`The following CMC items are identical to those approved in original NDA 21-372:
`
`0 Drug substance manufacturer, method of manufacture, Specifications, and stability
`
`
`Drug product formulation, method of manufacture (including sterilization), and manufacturing facility
`
`
`Drug product specifications (with the exception of the numerical value for fill volume) and test facility
`
`
`Composition of container closure system
`(b) (4)
`
`
`Stability protocol
`
` The following CMC items are different for the new package presentation (21—372/S-008):
`
`-
`Package presentation (cohgirzig closure system size).
`0
`
`
`
`The application was consulted to the microbiology staff for review, and was found acceptable regarding sterility
`assurance (Review noted, no comments — NAI signed by Bryan Riley).
`
` 16. Conclusions and Recommendations: Recommend approval from the standpoint of CMC. Adequate
`
` information was provided regarding the new presentation of the drug product.
`
`17. Name:
`
`
`Signature:
`Date: February 29, 2008
`David Lewis, Ph.D., Chemist
`
`
`
` 18. Concurrence:
`
`
`Signature:
`Hasmukh Patel, Ph.D., Branch Chief
`_
`
`
`ONDQA/DPME/Branch VIII
`
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`
`
`i
`
`Page(s) Withheld
`
`l/
`
`§ 552(b)(4) Trade Secret /
`
`Confidential
`
`——
`
`§ 552(b)(4) Draft Labeling
`
`——
`
`-
`
`§ 552(b)(5) Deliberative Process
`
`Withheld Track Number: Chemistry-«2" 519
`$000
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`David Lewis
`
`2/28/2008 05 17 01 PM
`CHEMIST
`
`Recommedn approval from the standpoint of CMC.
`See memo (separate E—mail message)
`to be forwarded to
`HFD—180
`
`Hasmukh Patel
`
`2/29/2008 08:26:20 AM
`CHEMIST
`
`
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