Tag Archives: Dificid

U.S. Food and Drug Administration (FDA) Has Accepted 2 New Drug Applications (NDA) for DIFICID (fidaxomicin) In Children Aged Six Months Or Older



Known as MSD outside the United States and Canada

announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for DIFICID ® (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides ) difficile infections (CDI) in children aged six months or older. Both applications have received a priority review classification by the FDA. The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020. The investigational pediatric indication for DIFICID was granted Orphan Drug Designation (ODD) in 2010.

“Evidence indicates the increasing incidence of C. difficile -associated diarrhea among hospitalized children 1,” said Dr. Nicholas Kartsonis, senior vice president, Clinical Research, infectious diseases and vaccines, Merck Research Laboratories. “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.”

The sNDA is based primarily on results of the Phase 3 SUNSHINE study 2, which were presented as part of the Late Breaker Oral Abstracts on Emerging Infections at IDWeek 2018 in San Francisco, California.

About DIFICID (fidaxomicin)

DIFICID is a macrolide antibacterial medicine indicated in adults (18 years of age or older) for treatment of Clostridium difficile -associated diarrhea (CDAD). To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridiumdifficile. DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID. DIFICID should only be used for the treatment of C. difficile-associated diarrhea. DIFICID is not effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin.

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AccessDIFICID (fidaxomicin) Is A Support Program For Patients Prescribed DIFICID®

Dificid (fidaxomicin)  Product Access and Support Information:

AccessDIFICID is a support program for patients who have been prescribed DIFICID® (fidaxomicin) tablets.

Case managers are available M-F, 8 am – 8 pm; SAT, 9 am – 1 pm, ET, to provide the following information and support:

  • Research your insurance benefits
  • Obtain information about your out-of-pocket costs
  • Provide information on co-pay assistance options
  • Provide a referral to the Patient Assistance Program (PAP)
  • Provide information about local pharmacies that stock DIFICID and/or options for overnight deliveries of DIFICID, where available, to the location of your choice
  • Answer questions about filling out the AccessDIFICID Enrollment Form

Getting started is simple

  • Download and complete the appropriate sections of the AccessDIFICID Enrollment Form with your health care provider
  • You or your health care provider can fax the completed form to 1-888-997-9329
  • A program representative will then contact you and your health care provider’s office
After your intake form has been processed, you will receive a phone call from an AccessDIFICID case manager, who will work with you throughout the process. You may also contact a case manager at 1-844-282-4782 (M-F, 8 am – 8 pm; SAT, 9 am – 1 pm, ET).

 For continued information for AccessDIFICID please click on the following link:



*The C Diff Foundation does not endorse this or any medical and non-medical treatment available for the
treatment of a C. difficile infection.  All possible treatment options are strictly information
based and for the general public and for general knowledge.   Discuss all treatment options
with the physician/s providing care for and and all diagnosis.  *

Dr. Nicholas Kartsonis Discusses Merck’s History In Infectious Disease and Their Ongoing Research Plus Some Of The Company’s Current Treatments, Including Dificid, To Address C. diff. Infections (CDI)

cdiffRadioLogoMarch2015                What’s new in the C Diff Foundation?

Let us introduce you to the first internet radio talk show dedicated to C. diff. and more……

C. diff. Spores and More”


UPCOMING SHOW:  TODAY ~ Tuesday, May 26th: 

 Dr. Nicholas Kartsonis;  Merck Research Laboratories (MRL)

Join us today, Tuesday, May 26th,  as our guest Dr. Nicholas Kartsonis , Associate Vice President of Clinical Research for Infectious Diseases for Merck Research Laboratories (MRL) and Section Head within MRL for antibiotics, antibacterials and cytomegalovirus  shares his time and discusses the past, present, and future contributions of Merck Research Laboratories.  

Dr. Kartsonis joined Merck Research Laboratories in February 2000 and has been actively involved in programs for new antibacterials, antifungals, anti-HIV, anti-CMV, and agents targeted against C. difficile infection.  Most recently, he has led the efforts to ensure the integration of the Cubist Pharmaceuticals clinical research portfolio within Merck. 

 Dr. Kartsonis will provide an overview of Merck’s current efforts to address the worldwide public health crisis posed by antimicrobial resistance, as well as the company’s history in infectious disease and antimicrobial stewardship. In addition, he will talk about the company’s current treatment for C. difficile and ongoing research efforts to address C. difficile infections (CDI).



We invite you to join us in listening to this exciting, new internet talk show that broadcasts live every Tuesday at the following times:


 Click Image Above to Listen to Archived Shows


PT 11a,  MT 12p, CT 1p, ET  2 p


We are pleased to share C. diff. Spores and More” with you because, as advocates of C. diff., we know how important this cutting-edge new weekly radio show means for our Foundation’s community worldwide.

Hard Facts: Deaths and illnesses are much higher than reports have shown. Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released today, February 25, 2015, by the Centers for Disease Control and Prevention (CDC).

• More than 100,000 of these infections developed among residents of U.S. nursing homes.

Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection. Of these 29,000 – 15,000 deaths were estimated to be directly related to a
C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.
Previous studies indicate that C. diff. has become the most common microbial cause of Healthcare-Associated Infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone. Approximately
two-thirds of C. diff. infections were found to be associated with an inpatient stay in a health care facility, only 24% of the total cases occurred in patients while they were hospitalized. The study also revealed that almost as many cases occurred in nursing homes as in hospitals and the remainder of individuals acquired the
Healthcare-Associated infection, C. diff., recently discharged from a health care facility.

This new study finds that 1 out of every 5 patients with the Healthcare-Associated Infection (HAI), C. diff., experience a recurrence of the infection and 1 out of every 9 patients over the age of 65 diagnosed with a HAI – C. diff. infection died within 30 days of being diagnosed. Older Americans are quite vulnerable to this life-threatening diarrhea infection. The CDC study also found that women and Caucasian individuals are at an increased risk of acquiring a C. diff. infection. The CDC Director, Dr. Tom Frieden, MD, MPH said, “C. difficile infections cause immense suffering and death for thousands of Americans each year.” “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

“This does not include the number of C. diff. infections taking place and being treated in other countries.”  “The  CDF supports hundreds of communities by sharing the CDF mission and    raising C. diff. awareness to healthcare professionals, individuals, patients, families,  and communities working towards a shared goal ~  witnessing a reduction of newly diagnosed            C. diff. cases by 2020 .”   ” The CDF Volunteers are greatly appreciated as they create positive changes sharing their time so generously worldwide aiding in the success of our mission and raising C. diff. awareness.”

C. diff. Spores and More” spotlights world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more.

Through their interviews, the CDF mission will connect, educate, and empower many worldwide.


Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.


Please join us Tuesdays in listening to the educational episodes of C. diff. Spores and More”

View the programs and radio information and access previous episodes available as a podcast by clicking on the link below:



Take our show on the go…………..download a mobile app today


C Diff Foundation’s “Raising C.diff Awareness” Continuing Education Workshop Launched in Community Colleges

cdiffhandwashingbreakpostercdiffInfControl Healthcare Professionals, employed in all areas of healthcare, attended the first “Raising C. diff. Awareness” Continuing Education class being offered in allied health at the Community Colleges.

Attendees learned about C. difficile prevention, treatments, and environmental safety.

ShelbyTeachingThe class learned how to prevent contamination with the opportunity to practice safe infection control techniques, discuss the physical, psychological, social, and financial impact this infection causes to a patient, families, and healthcare industry and how to prevent infections in their everyday practices.

Congratulations to all the attendees of “Raising C. diff. Awareness” Continuing Education Workshop – Spring Class 2015!  Each attendee learned something new today and each has a voice – Now is the time to take the knowledge and continue raising C. diff. awareness in every area of practice.  Each student joins us in the shared goal~  to witness a decrease in newly diagnosed   C. diff. infections worldwide.

Thank you to all who attended this workshop and it was a pleasure to provide you with valid information for C. diff. prevention, treatments, and environmental safety.

“None of us can do this alone…..all of us can do this together!”




LindaAngelo CdiffRCDA-3May2015 CdiffRCDAgroupMay2015 CdiffRCDA-5May2015 CdiffRCDA-7May2015

Taught by:
Nancy Caralla, Founding Executive Director C Diff Foundation,
Shelby Lassiter, RN, BSN, CPHQ, CIC, Consulting Infection Preventionist for C Diff Foundation
Karen Factor, RD, MBA, Chairperson Nutrition and Wellness C Diff Foundation
Angelo Ortiz, Treasurer, C Diff Foundation
Linda Davis, RN, BSN, Community Nurse for C Diff Foundation

Continuing Education through Durham Community Colleges

Dificid (fidaxomicin) a treatment for CDAD

The most recent antibiotic, Dificid (fidaxomicin) is the first medication approved by FDA to treat CDAD in twenty five years with superiority in sustained clinical response

DIFICID® is a macrolide antibacterial drug indicated in adults ≥18 years of age for treatment of Clostridium difficile-associated diarrhea.

For complete information available regarding this medication please visit their web-site: