Treats postmenopausal women with hormone receptor positive early breast cancer. NDA 20726, held by Novartis Pharms. Letrozole.
As of Nov 13, 2026, NDA 20726 (Femara), held by Novartis Pharms, was first approved by FDA on Jul 25, 1997, with 26 approved supplements and 0 published complete response letters.
Femara is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. 1.1 Adjuvant Treatment of Early Breast Cancer Femara (letrozole) is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 1.
| Apr 30, 2010 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Mar 2, 2010 | Supplement 16Efficacy (new indication or use) | Approved | |
| Mar 2, 2010 | Supplement 15Efficacy (new indication or use) | Approved | |
| Dec 28, 2005 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Oct 29, 2004 | Supplement 11Efficacy (new indication or use) | Approved | |
| Feb 26, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 17, 2003 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 10, 2001 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jul 25, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Femara2.5MG · tablet;oral | Letrozole | RxReference drug |
| Dec 16, 2024 | Supplement 43Labeling · Standard review | Approved | |
| Apr 5, 2018 | Supplement 35Labeling · Standard review | Approved | |
| Jul 13, 2017 | Supplement 33Labeling · Standard review | Approved | |
| Oct 28, 2016 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2015 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2014 | Supplement 27Labeling · Standard review | Approved | |
| Jul 11, 2013 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2011 | Supplement 24Labeling · Standard review | Approved | |
| Jun 25, 2010 | Supplement 19Labeling · Standard review | Approved | |
| Apr 30, 2010 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Mar 2, 2010 | Supplement 16Efficacy (new indication or use) | Approved | |
| Mar 2, 2010 | Supplement 15Efficacy (new indication or use) | Approved | |
| Jul 7, 2009 | Supplement 18Labeling · Standard review | Approved | |
| Aug 7, 2008 | Supplement 17Labeling · Standard review | Approved | |
| Apr 11, 2007 | Supplement 14Labeling · Standard review | Approved | |
| Jun 26, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Dec 28, 2005 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Oct 29, 2004 | Supplement 11Efficacy (new indication or use) | Approved | |
| Feb 26, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 17, 2003 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 10, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 5, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 10, 2001 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 23, 2000 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 17, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1997 | 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
