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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 21-266/S-031 SUPPLEMENTS APPROVAL
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`NDA 21-267/S-034
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`NDA 21-630/S-022
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`Pfizer, Inc.
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`Attention: Ms. Anne Palestroni
`
`
` Director, US Regulatory Affairs
`235 East 42nd Street
`New York, NY 10017-5755
`
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`Dear Ms. Palestroni:
`
`Please refer to your supplemental new drug applications (sNDAs) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for the following:
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`Drug Product Name
`
`
`NDA
`Number
`21-266
`
`Supplement
`Number
`S-031
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`Date of
`Supplement
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`June 18, 2010
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`Date of Receipt
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`June 18, 2010
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`21-267
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`21-630
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`S-034
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`S-022
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`June 18, 2010
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`June 18, 2010
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`June 18, 2010
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`June 18, 2010
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`VFEND® (voriconazole)
`Tablets, 50 mg and 200 mg
`VFEND® I.V. (voriconazole)
`for Injection, 10 mg/mL
`VFEND® (voriconazole) for
`Oral Suspension, 45 mg/mL
`
`
`We acknowledge receipt of your June 28 and December 9, 2010 amendments for all three NDAs.
`
`These Prior Approval supplemental new drug applications provide for revisions to the product
`labeling as they relate to the implementation plan for the January 24, 2006, Final Rule titled,
`Requirements on Content and Format of Labeling for Human Prescription Drug and Biological
`Products (Federal Register Vol. 71, No. 15, 3921-3997). Specifically, these sNDAs provide for
`conversion of the current approved labeling to the format required by the Physician Labeling
`Rule in accordance with 21 CFR 201.56 and 201.57.
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`We have completed our review of these supplemental new drug applications, as amended. They
`are approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
`
`
`
`Reference ID: 2878486
`
`

`

`
` NDA 21-266/S-031
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` NDA 21-267/S-034
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` NDA 21-630/S-022
`Page 2
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`Prescribing Information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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`CONTENT OF LABELING
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` As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
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`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert) and include the labeling changes
`proposed in any pending “Changes Being Effected” (CBE) supplements. 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.
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental new drug applications for these NDAs,
`including pending “Changes Being Effected” (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 these supplemental applications.
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`LABELING
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`Submit final printed labeling as soon as it is available, but no more than 30 days after it is
`printed. The final printed labeling (FPL) must be identical to the package insert.
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`The final printed labeling should be submitted electronically according to the guidance for
`industry titled “Providing Regulatory Submissions in Electronic Format – Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
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`(October 2005)”. Alternatively, you may submit 12 paper copies, with 6 of the copies
`individually mounted on heavy-weight paper or similar material. For administrative purposes,
`designate these submissions “Final Printed Labeling for approved NDA 21-266/S-031; NDA
`21-267/S-034; NDA 21-630/S-022.” Approval of these submissions by FDA is not required
`before the labeling is used.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`
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`Reference ID: 2878486
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`

`

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` NDA 21-266/S-031
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` NDA 21-267/S-034
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` NDA 21-630/S-022
`Page 3
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`24 hours prior to issuing the letter, an electronic copy of the letter to these NDAs, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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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 Jacquelyn Smith, M.A., Regulatory Health Project Manager, at
`(301) 796-1600.
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`Sincerely,
`
`{See appended electronic signature page}
`
`
` Renata Albrecht, M.D.
` Director
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` Division of Special Pathogen and Transplant Products
` Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Enclosure: Product Labeling
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`Reference ID: 2878486
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`RENATA ALBRECHT
`12/15/2010
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`Reference ID: 2878486
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`