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`
`U.S. FOOD & DRUG
`ADM INISTRATION
`
`NOA 021266/S-051
`NOA 021267/S-061
`N DA 021630/S-040
`
`PF PRISM C.V.
`c/o Pfizer Inc.
`Attention : Alka Abrol
`Manager, Global Regulatory Affairs
`Hospital Business Unit, Pfizer Biopharmaceutical Group
`100 Route 206 North
`New York, NY 07977
`
`Dear Mr. Abrol:
`
`SUPPLEMENT APPROVAL
`
`Please refer to your supplemental new drug applications (sNDAs) dated and received
`March 05, 2021 , and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for the following:
`
`NOA 021266/S-051 VFEND (voriconazole) tablets, 50 mg and 200 mg
`NOA 021267/S-061 VFEND (voriconazole) for injection, 200 mg
`NOA 021630/S-040 VFEND (voriconazole) for oral suspension, 40 mg/ml
`
`These Prior Approval sNDAs provide for revisions to the prescribing information (Pl) to
`include a contraindication for the use of lurasidone with voriconazole. Specifically, the
`following sections of the Pl have been revised :
`
`1) HIGHLIGHTS OF PRESCRIBING INFORMATION: under RECENT MAJOR
`CHANGES
`2) FULL PRESCRIBING INFORMATION:
`a. DOSAGE AND ADMINISTRATION (2) section, Dosage Modifications in
`Patients with Renal Impairment (2.6) subsection, Adult Patients
`b. DRUG INTERACTIONS (7) section, including Table 11; lurasidone has been
`added and text regarding midazolam has been modified .
`
`(b) (41
`
`C.
`
`Additionally, minor editorial updates have been made throughout the Pl including
`replacement of the term, "adverse events" with "adverse reactions" and corresponding
`updates have been made to the Patient Package Insert.
`
`Reference ID 4871269
`
`

`

`
`
`
`
`
`
` NDA 021266/S-051
`
` NDA 021267/S-061
`
` NDA 021630/S-040
`
` Page 2
`
`
` APPROVAL & LABELING
`
` We have completed our review of these applications, as amended. They are approved,
`
`
`
`
` effective on the date of this letter, for use as recommended in the enclosed agreed-
`
` upon labeling.
`
`
`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 314.50(l)] in structured product labeling (SPL) format using
`
`
`
`
`the FDA automated drug registration and listing system (eLIST), as described at
`
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`Prescribing Information, Patient Package Insert, and Instructions for Use), 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 SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`
`
`
`changes for these NDAs, 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 Microsoft Word
`
`format, that includes the changes approved in these supplemental applications, as well
`as annual reportable changes. To facilitate review of your submission(s), 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).
`
`
`
`All promotional materials that include representations about your drug product must be
`
`promptly revised to be consistent with the labeling changes approved in these
`
`
`
`
`supplements, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`
`
`
`in your promotional materials should include prominent disclosure of the important new
`
`
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`
`
`
`
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
`
`
`
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4871269
`
`

`

`
`
` NDA 021266/S-051
`
` NDA 021267/S-061
`
` NDA 021630/S-040
`
` Page 3
`
`
` 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 Alison Rodgers, Regulatory Project Manager, at
`
`301-796-0797.
`
`
`
`
`
`
`
`
`
`Sincerely,
`
`
`
`{See appended electronic signature page}
`
`
`Dmitri Iarikov, MD, PhD
`
`Deputy Director
`
`Division of Anti-Infectives
`
`Office of Infectious Diseases
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`ENCLOSURE(S):
`
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Patient Package Insert
`
`
`o Instructions for Use
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4871269
`
`

`

`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/
`------------------------------------------------------------
`
`DMITRI IARIKOV
`10/13/2021 08:15:40 AM
`
`Reference ID: 4871269
`
`