ARTICLE | Clinical News

Charleston resubmits NDA for pain candidate

October 20, 2017 12:29 AM UTC

Charleston Laboratories Inc. (Jupiter, Fla.) said it resubmitted an NDA to FDA for CL-108 to treat moderate to severe acute pain while preventing and reducing opioid-induced nausea and vomiting (OINV) for patients with pain severe enough to require an opioid.

FDA issued a complete response letter in February for the NDA from Charleston and then partner, Daiichi Sankyo Co. Ltd. (Tokyo:4568). At the time, the companies declined to comment on the details of the letter (see BioCentury, Feb. 8)...