For diabetes mellitus. BLA 21536, held by Novo Nordisk Inc. Insulin Detemir Recombinant.
As of Nov 13, 2026, BLA 21536 (Levemir, Levemir Flexpen, Levemir Innolet), held by Novo Nordisk Inc, was first approved by FDA on Jun 16, 2005, with 27 approved supplements and 0 published complete response letters.
LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2012 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Apr 27, 2012 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Mar 29, 2012 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2005 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levemir1000 UNITS/10ML (100 UNITS/ML) · injectable;subcutaneous | Insulin Detemir Recombinant | Rx |
| Levemir Flexpen300 UNITS/3ML (100 UNITS/ML) · injectable;subcutaneous | Insulin Detemir Recombinant | Discontinued |
| Levemir Innolet300 UNITS/3ML (100 UNITS/ML) · injectable;subcutaneous | Insulin Detemir Recombinant | Discontinued |
| Levemir Penfill300 UNITS/3ML (100 UNITS/ML) · injectable;subcutaneous | Insulin Detemir Recombinant | Discontinued |
| Levemir Flextouch300 UNITS/3ML (100 UNITS/ML) · injectable;subcutaneous | Insulin Detemir Recombinant | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2022 | Supplement 62Labeling · Standard review | Approved | |
| Jul 1, 2022 | Supplement 60Labeling · Standard review | Approved | |
| Dec 27, 2019 | Supplement 56Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 58Labeling | Approved | |
| Nov 15, 2019 | Supplement 57Labeling · Standard review | Approved | |
| Jan 17, 2019 | Supplement 54Labeling · Standard review | Approved | |
| Feb 25, 2015 | Supplement 51Labeling | Approved | |
| Feb 25, 2015 | Supplement 31Labeling · Standard review | Approved | |
| Jan 23, 2015 | Supplement 50Labeling · Standard review | Approved | |
| Jun 10, 2014 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Mar 4, 2014 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 25, 2014 | Supplement 48Labeling · Standard review | Approved | |
| Oct 31, 2013 | Supplement 33Labeling · Standard review | Approved | |
| Apr 10, 2013 | Supplement 44Labeling · Standard review | Approved | |
| Mar 9, 2013 | Supplement 35Labeling · Standard review | Approved | |
| Feb 15, 2013 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2012 | Supplement 28Labeling · Standard review | Approved | |
| May 18, 2012 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Apr 27, 2012 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Mar 29, 2012 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2012 | Supplement 29Labeling · Standard review | Approved | |
| Jan 22, 2010 | Supplement 30Manufacturing | Approved | None posted |
| May 7, 2009 | Supplement 24Labeling · Standard review | Approved | |
| Nov 28, 2008 | Supplement 23Labeling · Standard review | Approved | None posted |
| Sep 3, 2008 | Supplement 21Labeling · Standard review | Approved | |
| Sep 3, 2008 | Supplement 20Labeling · Standard review | Approved | |
| May 16, 2007 | Supplement 15Manufacturing | Approved | |
| Jun 16, 2005 | Original applicationNew molecular entity · Standard 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
