BLA 761046, held by Merck Sharp Dohme. Bezlotoxumab.
As of Nov 13, 2026, BLA 761046 (Zinplava), held by Merck Sharp Dohme, was first approved by FDA on Oct 21, 2016, with 1 approved supplement and 0 published complete response letters.
ZINPLAVA is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2023 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Oct 21, 2016 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zinplava1000ML/40ML · injectable;injection | Bezlotoxumab | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
