DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993

NDA 208562
TENTATIVE APPROVAL
Xellia Pharmaceuticals ApS
c/o Xellia Pharmaceuticals USA LLC
Attention: Edward Eichmann
US Regulatory Affairs Director
8900 Capital Boulevard
Raleigh, NC 27616

Dear Mr. Eichmann:
Please refer to your New Drug Application (NDA) dated July 24, 2015, received July 24, 2015,
and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act for Voriconazole for Injection, 200 mg.
This new drug application provides for the use of Voriconazole for Injection, 200 mg for the
treatment of invasive aspergillosis, candidemia in non-neutropenic patients and the following
candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder
wall, and wounds and serious fungal infections caused by Scedosporium apiospermum (asexual
form of Pseudallescheria boydii) and Fusarium spp. Including Fusarium solani, in patients
intolerant of, or refractory to, other therapy.
We have completed our review of this application, as amended. It is tentatively approved under
21 CFR 314.105 for use as recommended in the agreed-upon enclosed labeling text for the
package insert, carton and immediate container labels. This determination is based upon
information available to the Agency at this time, [i.e., information in your application and the
status of current good manufacturing practices (cGMPs) of the facilities used in the manufacture
and testing of the drug product]. This determination is subject to change on the basis of any new
information that may come to our attention.
One of the listed drugs upon which your application relies is subject to a period of patent and/or
exclusivity protection. This application is not eligible for approval because the 45-day period
described in section 505(c)(3)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) has not
yet expired.
To obtain final approval of this application, submit an amendment two or six months prior to the:
1.) expiration of the patent(s) and/or exclusivity protection or 2.) date you believe that your NDA
will be eligible for final approval, as appropriate. In your cover letter, clearly identify your
amendment as “REQUEST FOR FINAL APPROVAL”. This amendment should provide the
legal/regulatory basis for your request for final approval and should include a copy of any

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relevant court order or judgment settlement, or licensing agreement, as appropriate. In addition
to a safety update, the amendment should also identify changes, if any, in the conditions under
which your product was tentatively approved, i.e., updated labeling; chemistry, manufacturing,
and controls data; and risk evaluation and mitigation strategy (REMS). If there are no changes,
clearly state so in your cover letter. Any changes require our review before final approval and
the goal date for our review will be set accordingly.
Until we issue a final approval letter, this NDA is not deemed approved.
Please note that this drug product may not be marketed in the United States without final agency
approval under Section 505 of the Act. The introduction or delivery for introduction into
interstate commerce of this drug product before the final approval date is prohibited under
Section 501 of the Act and 21 U.S.C. 331(d).

PROPRIETARY NAME
If you intend to have a proprietary name for this product, the name and its use in the labels must
conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit
a request for a proposed proprietary name review. See the guidance for industry titled, “Contents
of a Complete Submission for the Evaluation of Proprietary Names”, at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/u
cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
2008 through 2012”.
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.
Because none of these criteria apply to your application, you are exempt from this requirement.

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If you have any questions, call Naseya Minor, Regulatory Project Manager, at (301) 796-0756.

Sincerely,
{See appended electronic signature page}

Sumathi Nambiar, MD, MPH
Director
Division of Anti-Infective Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research

ENCLOSURE(S):
Content of Labeling
Carton and Container Labeling

Reference ID: 3936152

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------SUMATHI NAMBIAR
05/24/2016

Reference ID: 3936152
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