Treats Clostridium difficil e‑associated diarrhea. NDA 208910, held by Azurity. Vancomycin Hydrochloride.
As of Nov 13, 2026, NDA 208910 (Firvanq Kit), held by Azurity, was first approved by FDA on Jan 26, 2018, with 3 approved supplements and 0 published complete response letters.
Vancomycin hydrochloride is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2018 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Firvanq KitEQ 25MG BASE/ML · for solution;oral | Vancomycin Hydrochloride | RxReference drug |
| Firvanq KitEQ 50MG BASE/ML · for solution;oral | Vancomycin Hydrochloride | RxReference drug |
| Feb 16, 2022 | Supplement 5Labeling · Standard review | Approved | |
| Jan 29, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Dec 13, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Jan 26, 2018 | 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
