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The health regulator concluded the company's application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic ...
The panel will deliberate whether the data provided by Merck establishes that a small reduction in cough frequency with the use of gefapixant is clinically meaningful to patients. US FDA staff ...
Gefapixant, sold under the brand name Lyfnua, is a medication used to treat chronic (long-term) cough. [1] It acts as an antagonist of the P2RX3 receptor. [2] [3] [4] It was approved for medical use in the European Union in September 2023. [1]
Benzonatate is a prescription non-opioid alternative for the symptomatic relief of cough.[7] [9] It has been found to improve cough associated with a variety of respiratory conditions including asthma, bronchitis, pneumonia, tuberculosis, pneumothorax, opioid-resistant cough in lung cancer, and emphysema.
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The oxomemazine ingredient (antihistamine) is not approved by the U.S. Food and Drug Administration (FDA), either for over the counter or prescription use. It is sold in France as cough syrup. French travelers also use it as a sleeping aid for long flights. [citation needed]
The approval for Germany and the EU was revoked in 2008. [5] Prior to withdrawal, it was available throughout Europe and Central America, as well as in South Africa. Trade names include Biotussin, Lomisat (Spain), Pertoxil (Italy), and in most of the world, Silomat. [6]
Oxolamine is not approved in the USA, it may be marketed elsewhere internationally as a cough suppressant. It is listed as a prescription drug in New Zealand legislation. Oxolamine is also approved in Taiwan for the treatment of respiratory tract inflammation .