CL-108 Approval Status
CL-108 (acetaminophen, hydrocodone and promethazine) is an analgesic and antihistamine fixed-dose combination in development for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).In February 2017, Charleston Laboratories, Inc., and Daiichi Sankyo, Inc. confirmed the receipt of a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CL-108 for the treatment of pain while reducing opioid-induced nausea and vomiting. The CRL stated that the NDA was not approvable in its present form, and provided guidance on information needed to resolve matters identified.
Development Status and FDA Approval Process for CL-108
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