May 2, 2014: Nonprescription Drugs Advisory Committee Meeting Announcement
|CDER||May 2, 2014
||8:00 a.m. to 4:30 p.m.
||Hilton Washington DC North/Gaithersburg
620 Perry Parkway, Gaithersburg, Maryland
The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- Written submissions may be made to the contact person on or before April 25, 2014.
- Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on May 2, 2014. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 17, 2014.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 18, 2014.
CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the May 2, 2014 Nonprescription Drugs Advisory Committee meeting.
- Kalyani Bhatt, BS, MS
Center for Drug Evalulation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Telephone: (301) 796-9001
Fax: (301) 847-8533
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kalyani Bhatt at (301) 796-9001 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).