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

NDA 205613
NDA APPROVAL
Salix Pharmaceuticals, Inc.
Attention: Jennifer Richards
Associate Director, Regulatory Affairs
8510 Colonnade Center Drive
Raleigh, NC 27615
Dear Ms. Richards:
Please refer to your New Drug Application (NDA) dated November 15, 2013, received
November 15, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (FDCA) for Uceris (budesonide) rectal foam, 2 mg.
We acknowledge receipt of your amendments dated December 16, 2013, January 13, 24, 28,
2014, February 05, 14, 18, 25, 27, 2014, March 05, 07, 18, 26(2), 2014, April 09, 15, 22, 30,
2014, May 12, 19, 23, 29, 2014, June 03, 04, 17(2), 25, 2014, July 02, 08, 10(2), 14, 15, 18,
22(3), 28, 31, 2014, August 07, 08, 15, 18(2), 22, 25, 26, 27, 2014, September 03, 05(2), 08, 10,
11, 12, 17, 2014 and October 03, 2014.
This new drug application provides for the use of Uceris (budesonide) rectal foam for the
induction of remission in patients with active mild to moderate distal ulcerative colitis extending
up to 40 cm from the anal verge.
We have completed our review of this application, as amended. It is approved, effective on the
date of this letter, for use as recommended 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 314.50(l)] in structured product labeling (SPL) format using the FDA
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 and text for the
patient package insert). 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, available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf.

Reference ID: 3640616

 NDA 205613
Page 2

The SPL will be accessible via publicly available labeling repositories.
CARTON AND IMMEDIATE CONTAINER LABELS
We acknowledge your September 17, 2014, submission containing final printed carton and
container labels.
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 this drug product for this indication has an orphan drug designation, you are exempt
from this requirement.
POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS
UNDER SECTION 506B
We remind you of your postmarketing commitments:
2800-1: A 6-week randomized, double blind, placebo-controlled trial in children 5 to 17 years of
age with active, mild to moderate distal ulcerative colitis (extending up to 40 cm from the anal
verge). The trial will evaluate pharmacokinetics (PK), efficacy for induction of remission, and
safety of at least 2 doses of Uceris (budesonide) rectal foam. The effects of 6 weeks of Uceris
(budesonide) rectal foam on the HPA axis will be assessed.
The timetable you submitted on September 5, 2014, states that you will conduct this study
according to the following schedule:
Final Protocol Submission:
Trial Completion:
Final Report Submission:

04/15
01/18
04/18

Submit clinical protocols to your IND 104725 for this product. Submit all postmarketing final
reports to this NDA. In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii) you
should include a status summary of each commitment in your annual report to this NDA. The
status summary should include expected summary completion and final report submission dates,
any changes in plans since the last annual report, and, for clinical studies/trials, number of
patients entered into each study/trial. All submissions, including supplements, relating to these
postmarketing commitments should be prominently labeled “Postmarketing Commitment
Protocol,” “Postmarketing Commitment Final Report,” or “Postmarketing Commitment
Correspondence.”

Reference ID: 3640616

 NDA 205613
Page 3

PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
proposed materials in draft or mock-up form with annotated references, and the package insert
to:
Food and Drug Administration 

Center for Drug Evaluation and Research

Office of Prescription Drug Promotion

5901-B Ammendale Road

Beltsville, MD 20705-1266

As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
2253. 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, contact Kelly Richards, Regulatory Project Manager, at (240) 402­
4276.
Sincerely,
{See appended electronic signature page}

Andrew E. Mulberg, MD, FAAP, CPI
Deputy Director
Division of Gastroenterology and Inborn Errors
Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research

Enclosure(s):
Content of Labeling
Carton and Container Labeling

Reference ID: 3640616

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------ANDREW E MULBERG
10/07/2014

Reference ID: 3640616