Daiichi Sankyo Inc.Welchol (colesevelam) chewable bar

NDA 210895 COMPLETE RESPONSE

Daiichi Sankyo Inc.

Attention: Linda Nelson, PhD Director, Regulatory Affairs 211 Mount Airy Road

Basking Ridge, NJ 07920-2311

Dear Dr. Nelson:

Please refer to your New Drug Application (NDA) dated and received October 30, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Welchol (colesevelam) chewable bar, 3.75 grams.

We also acknowledge receipt of your amendment dated May 31, 2018, containing additional chemistry, manufacturing and controls information which was not reviewed for this action. You may incorporate applicable sections of the amendment by specific reference as part of your response to the deficiencies cited in this letter.

We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues.

PRODUCT QUALITY During a recent inspection of the © drug product manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.

Satisfactory resolution of these deficiencies is required before this application may be approved.

PRESCRIBING INFORMATION

We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) — a checklist of important format items from labeling regulations and guidances.

If you revise labeling, use the SRPI checklist to ensure that the prescribing information conforms with format items in regulations and guidances. Your response must include updated content of labeling

[21 CFR 314.50(1)(1)(i)] in structured product labeling (SPL) format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

Reference ID: 4311552

NDA 210895 Page 2

PROPRIETARY NAME

Please refer to correspondence dated, April 12, 2018, which addresses the proposed proprietary name, Welchol. This name was found acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.

ADDITIONAL COMMENTS

We have the following comment/recommendation that is not an approvability issue: In the resubmission, provide 24-month stability data for the six registration batches © and all available stability data for the six demonstration batches Las

OTHER

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 314.65. You may also request an extension of time in which to resubmit the application.

A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft FDA Guidance for Industry, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” December 2017 at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.

The drug product may not be legally marketed until you have been notified in writing that this application is approved.

If you have any questions, call Kati Johnson, Senior Regulatory Project Manager, at (301) 796-1234. Sincerely, {See appended electronic signature page} James P. Smith, MD, MS Deputy Director Division of Metabolism and Endocrinology Products

Office of Drug Evaluation II Center for Drug Evaluation and Research

Reference ID: 4311552

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.

JAMES P SMITH 08/24/2018

Reference ID: 4311552