The FDA declared the application for CL-108, as it stands, not approved. | File photo
The U.S. Food and Drug Administration
issued a complete response letter in response to Daiichi Sankyo's new drug
application regarding CL-108, a drug used in treating and managing pain.
The FDA declared the application, as it stands, not approved and is providing guidance on information
needed to resolve the issues.
Based in New Jersey, Daiichi Sankyo is a pharmaceutical
manufacture working to address unmet health care needs.