Charleston Laboratories, and Daiichi Sankyo has confirmed that the US 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, and Daiichi Sankyo, intend to work closely with the FDA to address the points raised in this action.
Charleston Laboratories, Inc. is a privately held, specialty pharmaceutical company focused on the research and development of novel pain products that prevent the burdensome side effects related to opioid analgesics and other products. In August 2014, Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. entered into a strategic collaboration for the development and commercialization for the US of hydrocodone combination products, including CL-108.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets.
Us fda, information for nda, cl-108, daiichi sankyo, charleston labs
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