Treats C. difficile -associated diarrhea. NDA 213138, held by Cubist Pharms LLC. Fidaxomicin.
As of Nov 13, 2026, NDA 213138 (Dificid), held by Cubist Pharms LLC, was first approved by FDA on Jan 24, 2020, with 1 approved supplement and 0 published complete response letters.
DIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile -associated diarrhea. 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 C. difficile. 1.1 Clostridioides difficile -Associated Diarrhea DIFICID is indicated in adult and pediatric patients aged 6 months and older for the treatment of C. difficile -associated diarrhea (CDAD). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 24, 2020 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dificid40MG/ML · for suspension;oral | Fidaxomicin | RxReference drug |
| May 28, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Jan 24, 2020 | Original applicationNew formulation or manufacturer · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
