
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Merck in a statement announced that FDA’s advisory committee voted 12-1 that Gefapixant do not provide a clinically meaningful benefit to adults with refractory or unexplained chronic cough. Chronic cough is defined as a cough lasting longer than eight weeks and underlying chronic cough (UCC) is where the underlying cause cannot be identified despite a thorough evaluation.
Gefapixant(Lyfnua) is approved in Europe for chronic cough in Sep 2023.
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