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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21630/S-033
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`PF PRISM C.V.
`c/o Pfizer, Inc.
`Attention: Nadia Kirzecky
`Director, Pfizer Essential Health Global Regulatory Affairs Brands
`235 East 42nd Street
`New York, NY 10017
`
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`Dear Ms. Kirzecky:
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`Please refer to your Supplemental New Drug Application (sNDA) dated June 27, 2018, received
`June 27, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for Vfend (voriconazole) for oral suspension, 40 mg/mL.
`
`This Prior Approval supplemental new drug application provides for the following revisions to
`the carton and container labeling:
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`1) Replacement of “45g” and “(75 mL when reconstituted)” with the final volume of “75
`mL (when reconstituted)” on the principal display panel.
`2) Removal of the space between the “46°” and “F” under the header “Before
`reconstitution” on both the container label and carton labeling.
`3) Revision of the storage statements to read, “Before reconstitution: Store dry powder
`refrigerated at 2oC to 8oC (36oF to 46oF). After reconstitution: Store suspension at
`controlled room temperature, 15oC to 30oC (59oF to 86oF). Do not refrigerate or freeze.
`ANY UNUSED SUSPENSION SHOULD BE DISCARDED 14 DAYS AFTER
`RECONSTITUTION” on both the container label and carton label.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels as soon as they are available, but no more than 30 days
`after they are printed. Please submit these labels electronically according to the guidance for
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`Reference ID: 4330439
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`NDA 21630/S-033
`Page 2
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`industry titled Providing Regulatory Submissions in Electronic Format — Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(May 2015, Revision 3). For administrative purposes, designate this submission “Final Printed
`Carton and Container Labels for approved NDA 21630/S-033.” Approval of this submission
`by FDA is not required before the labeling is used.
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`REPORTING REQUIREMENTS
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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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`If you have any questions, call Alison Rodgers, Regulatory Project Manager, at 301-796-0797.
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`Sincerely,
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`{See appended electronic signature page}
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`Dmitri Iarikov, MD, PhD
`Deputy Director
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Carton and Container Labeling
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`Reference ID: 4330439
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
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`DMITRI IARIKOV
`10/04/2018
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`Reference ID: 4330439
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`(
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