Skip to main content
Search results
https://www.fda.gov/media/173307/download
over 1 year ago -
Pharmacovigilance II Product Name: Dificid (fidaxomicin) Pediatric Labeling Approval Date:...System (FAERS) reports for Dificid (fidaxomicin) in ...
https://www.fda.gov/media/173394/download
over 1 year ago -
...comparative dissolution) • Case 4: Fidaxomicin drug products – (1) Comparative...23 Case 4: Fidaxomicin Drug Products www.fda.gov 24 Fidaxomicin Drug ...
https://www.fda.gov/media/178566/download
9 months ago -
...treated with either vancomycin or fidaxomicin. rCDI can be treated with antibiotics...antibiotics, specifically vancomycin or fidaxomicin. Vancomycin ...
https://www.fda.gov/media/173395/download
over 1 year ago -
Nitazoxanide tablet Sucralfate tablet Fidaxomicin tablet Nitazoxanide suspension Sucralfate...Sucralfate suspension Fidaxomicin for suspension ...
https://www.fda.gov/drugs/development-resources/antibacterial-susceptibility-test-interpretive-criteria
4 days ago -
Oral Yes No Ethionamide* Oral No No Fidaxomicin* Oral No No Fosfomycin tromethamine
https://www.fda.gov/media/168274/download
almost 2 years ago -
...therapy options for rCDI include fidaxomicin and vancomycin; the regimens can...antibiotic agent received (vancomycin or fidaxomicin). FDA agreed that ...
https://www.fda.gov/media/168002/download
almost 2 years ago -
...therapy options for rCDI (e.g., fidaxomicin and vancomycin) can be complex and...antibacterial treatment with vancomycin or fidaxomicin. Subjects were ...
https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals
3 months ago -
Parkinson’s disease psychosis 2 208443 Fidaxomicin Tablets, 200 mg Actavis Laboratories...Laboratories FL, Inc. Dificid (Fidaxomicin) Tablets ...
https://www.fda.gov/media/170014/download
over 1 year ago -
...the current guidelines recommend fidaxomicin as the preferred agent for treatment...treatment have not been updated since fidaxomicin was approved for ...
https://www.fda.gov/media/167579/download
almost 2 years ago -
...antibacterial treatment with vancomycin or fidaxomicin. Participants were stratified by...antibacterial received (vancomycin or fidaxomicin) and age ...
https://www.fda.gov/media/179977/download
over 2 years ago -
RBX2660) Vancomycin, metronidazole fidaxomicin ¹Kokai-Kun (2019) Lancet Infect
https://www.fda.gov/advisory-committees/pediatric-advisory-committee/pediatric-advisory-recommendations-and-updates
5 months ago -
Summary 10/26/2023 Dificid (fidaxomicin) Dificid (fidaxomicin) Pediatric Postmarketing
https://www.fda.gov/media/161684/download
over 2 years ago -
...treatments include vancomycin or fidaxomicin, with vancomycin being the most...disruption of the gut microbiome. Fidaxomicin is relatively sparing of ...
https://www.fda.gov/media/115643/download
over 6 years ago -
Oral No No Ethionamide* Oral No No Fidaxomicin* Oral No No Fosfomycin tromethamine
https://www.fda.gov/media/162692/download
over 2 years ago -
...intravenous or oral metronidazole, 149 fidaxomicin, rifaximin, tigecycline, nitazoxanide...Advisory Committee meeting entitled Fidaxomicin for the ...
https://www.fda.gov/media/182650/download
over 8 years ago -
Aventis Pharmaceuticals 3/17/00 Fidaxomicin Merck Sharp & Dohme Corp./Cubist
https://www.fda.gov/media/180157/download
over 6 years ago -
Aventis Allergic rhinitis/urticaria Fidaxomicin 12/13/19 Cubist Clostridium difficile-associated
https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request
about 2 months ago -
...225 KB] Amendment 3 [PDF - 231 KB] Fidaxomicin Cubist 12/13/2019 Written Request
https://www.fda.gov/media/134156/download
over 8 years ago -
Aventis Pharmaceuticals 3/17/00 Fidaxomicin Merck Sharp & Dohme Corp./Cubist
https://www.fda.gov/media/163879/download
about 2 years ago -
...vancomycin or a ten-day course of fidaxomicin for patients experiencing a first...Microbiota Transplantation Is Superior to Fidaxomicin for Treatment ...