13 June 2016 – Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. today announced that the U.S. FDA has accepted for review the new drug application for CL-108 for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting.

CL-108 is a fixed-dose, immediate-release bi-layered tablet with a rapid release layer containing 12.5 mg of promethazine and a second layer containing 7.5 mg of hydrocodone and 325 mg of paracetamol.

The FDA has set a target action date under the PDUFA of 31 January 2017.

For more details, go to: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006458.html