May 2, 2014 8:00 a.m. to 4:30 p.m.: Nonprescription Drugs Advisory Committee Meeting Announcement.
May 2, 2014 8:00 a.m. to 4:30 p.m.: Nonprescription Drugs Advisory Committee Meeting Announcement
Hilton Washington DC North/Gaithersburg
620 Perry Parkway, Gaithersburg, Maryland
During this meeting, 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.
Please click HERE for the current roster of the Nonprescription Drugs Advisory Committee.
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