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

NDA 205739
NDA APPROVAL
Relypsa, Inc.
Attention: Sarah McNulty
Vice President, Regulatory Affairs
700 Saginaw Drive
Redwood City, CA 94063

Dear Ms. McNulty:
Please refer to your New Drug Application (NDA) dated October 21, 2014, received October 21,
2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
Veltassa (Patiromer) Powder for Oral Suspension, 8.4 g, 16.8 g, and 25.2 g.
We acknowledge receipt of your amendments dated November 3, December 9, and 22, 2014,
February 2, 4 (two), 18, 20, April 1, May 5, 7, 15 (two), 19, 20, 28, June 1, 15, 19, 25, 26, July 9,
10, 15, 20 (two), 29, August 10, 12, 24, September 4, October 7, 9, and 16, 2015.
This new drug application provides for the use of Veltassa (Patiromer) Powder for Oral
Suspension for the treatment of hyperkalemia.
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 Medication
Guide). 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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Page 2

CARTON AND IMMEDIATE CONTAINER LABELS
Submit final printed carton and immediate container labels that are identical to the enclosed
carton and immediate container labels, 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 205739” 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.
MARKET PACKAGE
Please submit one market package of the drug product when it is available to the following
address:
Sabry Soukehal
Food and Drug Administration
Center for Drug Evaluation and Research
White Oak Building 22, Room: 4170
10903 New Hampshire Avenue
Silver Spring, Maryland
Use zip code 20903 if shipping via United States Postal Service (USPS).
Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL, FedEx).
ADVISORY COMMITTEE
Your application for Veltassa was not referred to an FDA advisory committee because the
clinical trial design and efficacy endpoints are acceptable.
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 are deferring submission of your pediatric studies until September 2021, because this product
is ready for approval for use in adults and pediatric studies should be delayed until additional
safety or effectiveness data have been collected. Given its mechanism of action, Patiromer is
expected to be effective in treating hyperkalemia in pediatric patients; therefore, extrapolation of

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Page 3

efficacy is acceptable. However, safety, tolerability, and dosing data are needed to guide the use
of Patiromer in the pediatric population.
Your deferred pediatric studies required under section 505B(a) of the FDCA are required
postmarketing studies. The status of these postmarketing studies must be reported annually
according to 21 CFR 314.81 and section 505B(a)(3)(C) of the FDCA. These required studies are
listed below.
2980-1 

Study 1: A Phase 2, Open-Label, Multiple Dose Study to Evaluate the
Pharmacodynamic Effects, Safety, and Tolerability of Veltassa (Patiromer
Sorbitex Calcium) for Oral Suspension in Children and Adolescents 2 to 18 Years
of Age with Hyperkalemia
Final Protocol Submission:
Study Completion:
Final Report Submission:

2980-2 

03/2016

12/2020

09/2021


Study 2: A Phase 2, Open-Label, Multiple Dose Study to Evaluate the
Pharmacodynamic Effects, Safety, and Tolerability of Veltassa (Patiromer
Sorbitex Calcium) for Oral Suspension in Infants and Toddlers Under 2 Years of
Age with Hyperkalemia
Final Protocol Submission:
Study Completion:
Final Report Submission:

03/2020

11/2024

07/2025


Submit the protocol(s) to your IND 75615, with a cross-reference letter to this NDA.
Reports of these required pediatric postmarketing studies must be submitted as a new drug
application (NDA) or as a supplement to your approved NDA with the proposed labeling
changes you believe are warranted based on the data derived from these studies. When
submitting the reports, please clearly mark your submission "SUBMISSION OF REQUIRED
PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of
the submission.
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:

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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).
MEDWATCH-TO-MANUFACTURER PROGRAM
The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
event reports that are received directly by the FDA. New molecular entities and important new
biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
copies of reports for this product. To participate in the program, please see the enrollment
instructions and program description details at
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.

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POST APPROVAL FEEDBACK MEETING
New molecular entities and new biologics qualify for a post approval feedback meeting. Such
meetings are used to discuss the quality of the application and to evaluate the communication
process during drug development and marketing application review. The purpose is to learn
from successful aspects of the review process and to identify areas that could benefit from
improvement. If you would like to have such a meeting with us, call the Regulatory Project
Manager for this application.
PDUFA V APPLICANT INTERVIEW
FDA has contracted with Eastern Research Group, Inc. (ERG) to conduct an independent interim
and final assessment of the Program for Enhanced Review Transparency and Communication for
NME NDAs and Original BLAs under PDUFA V (‘the Program’). The PDUFA V Commitment
Letter states that these assessments will include interviews with applicants following FDA action
on applications reviewed in the Program. For this purpose, first-cycle actions include approvals,
complete responses, and withdrawals after filing. The purpose of the interview is to better
understand applicant experiences with the Program and its ability to improve transparency and
communication during FDA review.
ERG will contact you to schedule a PDUFA V applicant interview and provide specifics about
the interview process. Your responses during the interview will be confidential with respect to
the FDA review team. ERG has signed a non-disclosure agreement and will not disclose any
identifying information to anyone outside their project team. They will report only anonymized
results and findings in the interim and final assessments. Members of the FDA review team will
be interviewed by ERG separately. While your participation in the interview is voluntary, your
feedback will be helpful to these assessments.
If you have any questions, please contact Sabry Soukehal, Consumer Safety Officer, at (240) 402
6187.
Sincerely,
{See appended electronic signature page}

Ellis F. Unger, MD
Director
Office of Drug Evaluation 1
Office of New Drugs
Center for Drug Evaluation and Research

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

Reference ID: 3836559

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------ELLIS F UNGER
10/21/2015

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Reference ID: 3836559