The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for September 9, 2018. The primary purpose of the meeting is to consider the following matter:
- Request for Schedule III status for esomeprazole magnesium trihydrate 20mg delayed release capsules when sold for the 14-day treatment for frequent heartburn for the following package sizes: 280mg (14 capsules), 560mg (28 capsules), 840mg (42 capsules).
Individuals, companies or organizations seeking Interested Party status for this agenda item are invited to contact NAPRA as soon as possible. All requests for Interested Party status must be submitted in writing to the NDSAC Secretariat via regular mail or email no later than 4:00 p.m. (EDT) on Thursday, July 26, 2018.
Individuals, companies or organizations who chose not to pursue Interested Party status or have been denied the status can provide comments, in writing, related to the agenda item outlined above. The comments must be received by the NDSAC Secretariat via regular mail or email no later than 4:00 p.m. (EDT) on Friday, August 31, 2018. Please note: only an acknowledgement of receipt for the comments received will be provided. All comments or information provided by this alternate method of participation shall be provided to NAPRA and any person, association or other entity that has obtained Interested Party status.
For more information, please contact Sarah Marshall, Manager, Professional and Regulatory Affairs, NAPRA at 613-569-9658, ext. 230 or via email at firstname.lastname@example.org