FDA CRL - Daiichi Sankyo, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Daiichi Sankyo Inc. regarding its New Drug Application (NDA 210895) for Welchol (colesevelam) chewable bar, 3.75 grams. The FDA determined the application could not be approved in its current form, citing several key issues. A primary concern arose from deficiencies observed during a recent inspection of the drug product manufacturing facility, requiring satisfactory resolution. Additionally, the proposed prescribing information was not considered adequate, and the agency reserved further comment on labeling until other issues are addressed. Daiichi Sankyo is required to resubmit the proposed proprietary name, which was previously deemed acceptable pending application approval. Furthermore, the company must provide 24-month stability data for six registration batches and all available stability data for six demonstration batches. To address these deficiencies, Daiichi Sankyo must provide a complete response within one year, including updated content of labeling in a structured product labeling (SPL) format, and ensure all manufacturing and data requirements are met for the NDA to be considered for approval.