CL-108 FDA Approval Status
FDA Approved: No
Brand name: CL-108
Generic name: acetaminophen, hydrocodone and promethazine
Company: Charleston Laboratories, Inc. and Daiichi Sankyo, Inc.
Treatment for: Pain, Nausea/Vomiting
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 timeline for CL-108
Further information
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