Merck says FDA seeks more data on Emend injection
CHICAGO, May 11 (Reuters) - Merck & Co. (MRK.N) on Friday said U.S. regulators want more data on its experimental injectable drug for nausea caused by chemotherapy, before granting approval for the treatment.
The drugmaker said the U.S. Food and Drug Administration has requested additional manufacturing and stability data, among other data sought, before it will clear the injectable drug for sale.
Once Merck responds to the so-called approvable letter from the FDA, review is expected to take six months, the company said.
Merck said the request does not affect the manufacturing and availability of an oral form of the drug, which the agency approved last year for post-operative nausea.
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