Sold as Bicnu, Gliadel, Carmustine. Every FDA application for this active ingredient: 3 branded and 11 generic.
As of Nov 13, 2026, FDA lists 14 applications for Carmustine (sold as Bicnu, Gliadel, Carmustine), first approved Mar 7, 1977, with 1 new use approved and 1 published complete response letter.
| Product | Part | Spending, 2024 | Change | Beneficiaries |
|---|---|---|---|---|
| Bicnu | Part B | $147K | -16% | 72 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 7, 1977 | BicnuNDA 17422 · New molecular entity | Avet Lifesciences | 42 | Marketed |
| Sep 23, 1996 | GliadelNDA 20637 · New dosage form | Azurity | 21 | Marketed |
| Sep 11, 2018 | CarmustineANDA 210179 | Navinta LLC | 0 | Marketed |
| Oct 16, 2018 | CarmustineANDA 211229 | Amneal | 0 | Marketed |
| Apr 2, 2019 | CarmustineANDA 209278 | Penn Life | 0 | Marketed |
| Oct 22, 2020 | CarmustineANDA 213207 | Dr Reddys | 0 | Marketed |
| Mar 12, 2021 | CarmustineANDA 211202 | Hengrui Pharma | 0 | Discontinued |
| Aug 2, 2021 | CarmustineANDA 213460 | Meitheal | 0 | Marketed |
| May 16, 2022 | CarmustineNDA 215000 · New active ingredient | Accord Hlthcare | 0 | Discontinued |
| Jun 21, 2022 | CarmustineANDA 211011 | Ingenus Pharms LLC | 0 | Discontinued |
| Dec 27, 2022 | CarmustineANDA 214117 | Accord Hlthcare | 0 | Discontinued |
| Mar 3, 2023 | CarmustineANDA 215368 | Pharmobedient | 0 | Discontinued |
| May 11, 2023 | CarmustineANDA 214814 | Msn | 0 | Marketed |
| Oct 20, 2023 | CarmustineANDA 215730 | Alembic | 0 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Apr 30, 2021 | CarmustineProduct Quality | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
