Treats delayed neutrophil recovery or graft failure after autologous or allogeneic bone…. BLA 103362, held by Berlex Labs. Sargramostim.
As of Nov 13, 2026, BLA 103362 (Leukine), held by Berlex Labs, was first approved by FDA on Mar 5, 1991, with 8 approved supplements and 0 published complete response letters.
LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2018 | Supplement 5240Efficacy (new indication or use) · Priority review | Approved | |
| Dec 22, 1995 | Supplement 1045Efficacy (new indication or use) | Approved | None posted |
| Nov 24, 1995 | Supplement 1048Efficacy (new indication or use) | Approved | None posted |
| Sep 15, 1995 | Supplement 1033Efficacy (new indication or use) | Approved | None posted |
| Mar 5, 1991 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leukine250UG/ML · vial | Sargramostim | Rx |
| Leukine500UG/ML · vial | Sargramostim | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2022 | Supplement 5249Labeling · Standard review | Approved | |
| Mar 29, 2018 | Supplement 5240Efficacy (new indication or use) · Priority review | Approved | |
| Feb 10, 2017 | Supplement 5237Labeling · Standard review | Approved | |
| Nov 4, 2008 | Supplement 5140Labeling · Standard review | Approved | None posted |
| Mar 14, 2002 | Supplement 5012Labeling · Standard review | Approved | None posted |
| Dec 22, 1995 | Supplement 1045Efficacy (new indication or use) | Approved | None posted |
| Nov 24, 1995 | Supplement 1048Efficacy (new indication or use) | Approved | None posted |
| Sep 15, 1995 | Supplement 1033Efficacy (new indication or use) | Approved | None posted |
| Mar 5, 1991 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
