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Merck & Co. (NYSE: MRK): DIFICID PDUFA Date
Merck is looking forward to the potential approval of a new indication for DIFICID. The PDUFA date for the supplemental New Drug Application is Friday, January 24, 2020.
DIFICID has been on the market for quite some time now. In 2011, the drug was approved as a treatment for patients with Clostridium difficile-associated diarrhea.
In October of 2019, the United States Food and Drug Administration accepted a supplemental New Drug Application from MRK with the goal of expanding the drug’s label.
The previous label does not allow for the drug to be given to pediatric patients. However, that may all change. If the sNDA is approved, DIFICID will be able to be prescribed to all patients with Clostridium difficile-associated diarrhea ages six months and old.
Of course, if the sNDA is approved, it will be a big win for MRK, greatly expanding the potential audience for the treatment and leading to gains in revenue and earnings. As such, this could send the stock screaming.