Merck Cough Drug Rejected as FDA Seeks More Information – Bloomberg


Merck & Co. said U.S. regulators declined to approve the company’s application for its experimental chronic-cough drug in its current form, a setback as the drugmaker seeks new potential blockbusters. 
The U.S. Food and Drug Administration sent Merck a complete response letter requesting additional information regarding the measurement of efficacy of the medication, gefapixant, according to a statement on Monday from the Kenilworth, New Jersey-based company. Merck said the agency’s decision wasn’t related to the safety of the drug.

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