§+
`
`{ DEPARTNIENTOFHEALTH&HUMAN
`
`1,,
`14”
`"Wm
`
`NBA 021372/S-018
`
`NDA 021372/S-019
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`FULFILLNIENT 0F POSTMARKETING REQUIREMENTS
`
`SUPPLEMENT APPROVAL
`
`Helsinn Healthcare SA
`
`c/o August Consulting, Inc.
`Attention: Craig Lehmann, PharmD.
`Authorized Representative
`515 S. Capital of Texas Hwy., Suite #150
`Austin, TX 78746
`
`Dear Dr. Lehmann:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated November 27, 2013
`and November 28, 2013, received November 27, 2013 and November 29, 2013, submitted under
`
`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Aloxi (palonosetron
`hydrochloride) Injection.
`
`We acknowledge receipt of your amendments dated May 27, 2014, May 20, 2014, April 30,
`2014, April 4, 2014, April 2, 2014, March 27, 2014, March 24, 2014, March 11, 2014, February
`27, 2014, February 24, 2014, and February 4, 2014.
`
`(m4)
`
`Prior Approval supplemental new drug application S-018 provides for
`updates to the Use in Specific Populations section of the package insert. The agreed-upon labeling
`changes reflect the lack of efiicacy in the pediatric patient population.
`
`Prior Approval supplemental new drug application S-019 provides for the prevention of nausea
`and vomiting associated with cancer chemotherapy in pediatric patients 1 month and older.
`
`APPROVAL & LABELING
`
`We have completed our review of these supplemental applications, as amended. They are
`approved, efl'ective on the date of this letter, for use as reconnnended in the enclosed, agreed-
`upon labeling text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 3 1450(1)] in structured product labeling (SPL) format using the FDA
`
`Reference ID: 3513457
`
`

`

`
`
`
`
`
`
`
`
`
`
`
` NDA 021372/S-018
`
` NDA 021372/S-019
`
` Page 2
`
`
` automated drug registration and listing system (eLIST), as described at
`
` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`
`patient package insert), with the addition of any labeling changes in pending “Changes Being
`
`
`
`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
`
`
`
`labeling.
`
`
`
`
` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As at
`
`
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`
` The SPL will be accessible from publicly available labeling repositories.
`
` Also within 14 days, amend all pending supplemental applications that include labeling changes
`
`
`
` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`
`
`
`
`
` changes approved in this supplemental application, as well as annual reportable changes and
`
`
`
` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`
` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`
`
`
`
`
`
`
` should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
`
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`
`administration are required to contain an assessment of the safety and effectiveness of the
`
`
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`
`deferred, or inapplicable.
`
`
`We note that you have fulfilled the pediatric studies requirement for all relevant pediatric age
`
`
`groups for this application.
`
`
`
`FULFILLMENT OF POSTMARKETING REQUIREMENTS
`
`We have received your submissions dated November 27 and 28, 2013, reporting on the following
`
`
`
`postmarketing requirements listed in the February 29, 2008 approval letter and August 3, 2005
`
`
`
`
`Pediatric Deferral granted letter.
`
`
`
`
`Deferred pediatric study under PREA to evaluate (1) the safety and
`
`
`tolerability of two doses of I.V. palonosetron for the prevention of
`
`
`
`postoperative nausea and vomiting, and (2) the efficacy of these two I.V.
`
`
`palonosetron doses to prevent postoperative nausea and vomiting.
`
`
`
`
`120-1
`
`
`
`
`Reference ID: 3513457
`
`

`

`
` NDA 021372/S-018
`
` NDA 021372/S-019
`
` Page 3
`
`
`
`806-1
`
`
`
`
`
`806-2
`
`
`
`
`
` Deferred pediatric study under PREA for the prevention of acute nausea and
`
` vomiting associated with initial and repeat courses of moderately and highly
`
`emetogenic cancer chemotherapy (CINV) in pediatric patients 1 month to 17
`years of age.
`
`
`Deferred pediatric study under PREA for the prevention of delayed nausea
`
`
`and vomiting associated with initial and repeat courses of moderately
`
`emetogenic cancer chemotherapy (CINV) in pediatric patients 1 month to 17
`
`years of age.
`
`
`
`
`
`We have reviewed your submission and conclude that the above requirements were fulfilled.
`
`This completes all of your postmarketing requirements acknowledged in our August 3, 2005 and
`
`
`
`February 29, 2008 letters.
`
`
`
`PROMOTIONAL MATERIALS
`
`
`
`You may request advisory comments on proposed introductory advertising and promotional
`
`
`
`
`
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`
`
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
`
`
`
`Food and Drug Administration
`
`
`Center for Drug Evaluation and Research
`
`
`Office of Prescription Drug Promotion (OPDP)
`
`
`5901-B Ammendale Road
`
`
`Beltsville, MD 20705-1266
`
`
`
`
`You must submit final promotional materials and package insert(s), accompanied by a Form
`
`
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`
`
`
`
`
`FDA 2253 is available at
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`
`more information about submission of promotional materials to the Office of Prescription Drug
`
`
`
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`If you have any questions, call Mary Chung, Regulatory Project Manager, at (301) 796-0260.
`
`
`
`
`
`
`
`
`Sincerely,
`
`
`
`Reference ID: 3513457
`
`

`

`NDA 021372/S-018
`NDA 021372/S-019
`Page 4
`
`
`
`
`ENCLOSURE(S):
`Content of Labeling
`
`
`{See appended electronic signature page}
`
`Donna Griebel, M.D.
`Division Director
`Division of Gastroenterology and Inborn Errors
`Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
`
`Reference ID: 3513457
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`DONNA J GRIEBEL
`05/27/2014
`
`Reference ID: 3513457
`
`