Charleston Laboratories completes pre-IND meeting
Charleston Laboratories, a specialty pharmaceutical company focused on the R&D of novel pain products, has announced the completion of its scheduled pre-IND meeting with the FDA for CL-H1T, a novel treatment for patients who have migraine pain and migraine induced nausea or vomiting.
"The pre-IND meeting with FDA's Division of Neurology Products (DNP) was positive and productive," said John Ameling, vice president of regulatory affairs at Charleston. "The questions we raised in the briefing document were answered and clarified in the meeting. I am confident that Charleston will be able to conduct the drug development program and submit an approvable NDA."