Daiichi Sankyo, Inc.: BLA 761366

1. Following pre-license inspection of Ch)

, listed in this application, FDA conveyed deficiencies to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA Form 483 prior to your resubmission of the application.

Your resubmission should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies will be evaluated upon receipt of the resubmission and may include re-inspection of the facility.

Type A) prior to application resubmission to discuss alternative trial(s) that may verify clinical benefit after a potential accelerated approval.

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.