Charleston Laboratories and Daiichi Sankyo confirmed that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CL-108 (hydrocodone, acetaminophen, promethazine), an investigational treatment for the management of pain severe enough to require an opioid analgesic while preventing or reducing the associated opioid-induced nausea and vomiting when alternative treatments for pain are inadequate.
The CRL stated that the NDA in its present form was not approved and provided guidance on information needed to resolve matters identified. Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. intend to work closely with the FDA to address the points raised in this action.