Treats chronic severe. BLA 761054, held by Samsung Bioepis Co Ltd. Infliximab-Abda.
As of Nov 13, 2026, BLA 761054 (Renflexis), held by Samsung Bioepis Co Ltd, was first approved by FDA on Apr 21, 2017, with 5 approved supplements and 0 published complete response letters.
RENFLEXIS is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2019 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Renflexis100MG · injectable;injection | Infliximab-Abda | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2025 | Supplement 41Labeling · Standard review | Approved | |
| Dec 26, 2023 | Supplement 21Labeling · Standard review | Approved | |
| Jan 27, 2022 | Supplement 29Manufacturing | Approved | |
| Jun 26, 2019 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Apr 21, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
