For non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). NDA 22311, held by Genzyme. Plerixafor.
As of Nov 14, 2026, NDA 22311 (Mozobil), held by Genzyme, was first approved by FDA on Dec 15, 2008, with 11 approved supplements and 0 published complete response letters.
Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2008 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mozobil24MG/1.2ML (20MG/ML) · solution;subcutaneous | Plerixafor | RxReference drug |
| Sep 21, 2023 | Supplement 23Labeling · Standard review | Approved | |
| Aug 19, 2020 | Supplement 22Labeling · Standard review | Approved | |
| May 30, 2019 | Supplement 20Labeling · Standard review | Approved | |
| Dec 1, 2017 | Supplement 18Labeling · Standard review | Approved | |
| May 12, 2016 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 4, 2015 | Supplement 16Labeling · Standard review | Approved | |
| Dec 4, 2014 | Supplement 15Labeling · Standard review | Approved | |
| Nov 12, 2013 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jun 4, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Feb 26, 2013 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jun 14, 2010 | Supplement 1Labeling | Approved | |
| Dec 15, 2008 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
