Skip to Content

CL-108 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 Status and FDA Approval Process 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.