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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

Oct 17, 2017Charleston Laboratories, Inc. Resubmits NDA for CL-108
Feb  3, 2017Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for NDA for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets
Jun 13, 2016Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108

Further information

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