Merck’s Two Applications For DIFICID® Drug On Review Priority List Of FDA

By John Heerdink LinkedIn

Merck & Co., Inc.  (MRK) is a global healthcare solutions provider that has been working towards bringing forward medicine and vaccines for some of the world’s most challenging diseases for more than a century.  They are committed to increasing health care access and continue to be at the leading edge of research. Merck has the industry’s largest immuno-oncology clinical research program.

As per reports, FDA has approved Merck’s New Drug Application for DIFICID® oral suspension for priority review along with a new indication for use of DIFICID tablets and oral suspension used for the treatment of Clostridium difficile infections (CDI) in children aged six months or older. CDI is one of the most common elements of healthcare-associated infections in U.S. hospitals. The target action date for both applications is due for Jan. 24, 2020.

“The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for DIFICID tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs,” stated Dr. Nicholas Kartsonis, senior vice president, Clinical Research, infectious diseases and vaccines, Merck Research Laboratories.

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(Read Original Story: FDA Accepts Two Applications for Merck’s DIFICID® (fidaxomicin) to Treat Children Aged Six Months Up to 18 years with Clostridium difficile Infections in Business Wire)


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