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

NDA 208143
NDA APPROVAL
Bracco Diagnostics Inc.
Attention: Melanie Benson
Director, US Regulatory Operations
259 Prospect Plains Rd.
Building H
Monroe Township, NJ 08831

Dear Ms. Benson:
Please refer to your New Drug Application (NDA) dated December 18, 2014, received
December 18, 2014, and your amendments, submitted pursuant to section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act (FDCA) for Act for READI-CAT 2 (barium sulfate) oral
suspension 2% (w/v) and READI-CAT 2 SMOOTHIE (barium sulfate) oral suspension 2%
(w/v).
We acknowledge receipt of your major amendment dated September 1, 2015, which extended
the goal date by three months.
This new drug application provides for the use of READI-CAT 2 (barium sulfate) oral
suspension for use in computed tomography of the abdomen to delineate the gastrointestinal tract
in adult and pediatric patients to opacify the gastrointestinal tract.
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. 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.
The SPL will be accessible via publicly available labeling repositories.

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CARTON AND IMMEDIATE CONTAINER LABELS
Submit final printed carton and immediate container labels that are identical to the carton and
immediate container labels submitted on January 11, 2016, 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 industry Providing Regulatory Submissions in Electronic Format – Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
(June 2008). 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 this
submission “Final Printed Carton and Container Labels for approved NDA 208143.”
Approval of this submission by FDA is not required before the labeling is used.
Marketing the product with FPL that is not identical to the approved labeling text may render the
product misbranded and an unapproved new drug.
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.
We note that you have fulfilled the pediatric studies requirement for all relevant pediatric age
groups for this application.
POSTMARKETING COMMITMENTS NOT SUBJECT TO THE REPORTING
REQUIREMENTS UNDER SECTION 506B
We remind you of your postmarketing commitments:
3024-1

(b) (4)

Use the USP method to screen the starting material,
. If a positive test is
(b)
obtained greater than (4) ppm for heavy metals, then use the ICP-MS method.
Validate the analytical ICP-MS method for detection of heavy metals in the drug
(b) (4)
substance
and provide data
from your validation studies with revised specifications.

The timetable you submitted on January 15, 2016, states that you will conduct this study
according to the following schedule:
Final Report Submission:

January 2017

Submit nonclinical and chemistry, manufacturing, and controls protocols and 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.

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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.”
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,
Medication Guide, and patient PI (as applicable) to:

OPDP Regulatory Project Manager

Food and Drug Administration 

Center for Drug Evaluation and Research

Office of Prescription Drug Promotion

5901-B Ammendale Road

Beltsville, MD 20705-1266

Alternatively, you may submit a request for advisory comments electronically in eCTD format.
For more information about submitting promotional materials in eCTD format, see the draft
Guidance for Industry (available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM443702.pdf ).
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).

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If you have any questions, call Frank Lutterodt, Regulatory Project Manager, at (301) 796-4251.
Sincerely,
{See appended electronic signature page}

Charles Ganley, M.D.
Director
Office of Drug Evaluation IV
Center for Drug Evaluation and Research

Enclosures:
Content of Labeling
Carton and Container Labeling

Reference ID: 3874601

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------CHARLES J GANLEY
01/15/2016

Reference ID: 3874601