Treats essential thrombocythemia. BLA 761166, held by Pharmaessentia Corp. Ropeginterferon Alfa-2b-Njft.
As of Nov 13, 2026, BLA 761166 (Besremi), held by Pharmaessentia Corp, was first approved by FDA on Nov 12, 2021, with 4 approved supplements and 1 published complete response letter.
BESREMi is an interferon alfa-2b indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2026 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 12, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 12, 2021 | BLA 761166Human Factors, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Besremi500 MCG/ML · injectable;subcutaneous | Ropeginterferon Alfa-2b-Njft | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2026 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 26, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Apr 29, 2024 | Supplement 7Labeling · Standard review | Approved | |
| May 25, 2023 | Supplement 3Manufacturing | Approved | |
| Nov 12, 2021 | Original applicationNew molecular entity · 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
