For diabetes mellitus. BLA 21081, held by Sanofi Aventis US. Insulin Glargine Recombinant.
As of Nov 14, 2026, BLA 21081 (Lantus, Lantus Solostar), held by Sanofi Aventis US, was first approved by FDA on Apr 20, 2000, with 28 approved supplements and 0 published complete response letters.
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
| Jul 17, 2015 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2013 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2009 | Supplement 34Efficacy (new indication or use) | Approved | |
| May 1, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Apr 20, 2000 | Original applicationNew molecular entity · Standard review | Approved |
| Lantus100 UNITS/ML · injectable;injection | Insulin Glargine Recombinant | Rx |
| Lantus Solostar300 UNITS/3ML (100 UNITS/ML) · injectable;injection | Insulin Glargine Recombinant | Rx |
| Jun 29, 2023 | Supplement 79Labeling · Standard review | Approved | |
| Jun 29, 2023 | Supplement 78Labeling · Standard review | Approved | |
| Jun 7, 2022 | Supplement 76Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 74Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 73Labeling · Standard review | Approved | |
| May 9, 2019 | Supplement 72Labeling · Standard review | Approved | |
| Nov 29, 2018 | Supplement 71Labeling · Standard review | Approved | |
| Apr 13, 2016 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Jul 17, 2015 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2015 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Feb 25, 2015 | Supplement 62Labeling | Approved | |
| Sep 5, 2014 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2013 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2013 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2013 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2013 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| May 16, 2013 | Supplement 55Labeling · Standard review | Approved | |
| Mar 27, 2013 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Sep 9, 2009 | Supplement 34Efficacy (new indication or use) | Approved | |
| Apr 25, 2007 | Supplement 24Manufacturing | Approved | |
| Mar 15, 2005 | Supplement 17Manufacturing · Standard review | Approved | |
| Feb 11, 2005 | Supplement 14Manufacturing · Standard review | Approved | |
| Aug 10, 2004 | Supplement 11Manufacturing · Standard review | Approved | |
| May 1, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 2002 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 7, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 31, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 17, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 20, 2000 | 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
