Prevents osteoporosis in postmenopausal women ( 1.1, 1.2 ). NDA 20560, held by Organon. Alendronate Sodium.
As of Nov 14, 2026, NDA 20560 (Fosamax), held by Organon, was first approved by FDA on Sep 29, 1995, with 53 approved supplements and 0 published complete response letters.
FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1, 1.2 ) Treatment to increase bone mass in men with osteoporosis Treatment of glucocorticoid-induced osteoporosis Treatment of Paget's disease of bone Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX is indicated for the treatment of osteoporosis in postmenopausal women.
| Dec 21, 2005 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Apr 16, 2004 | Supplement 41Efficacy (new indication or use) | Approved | |
| Jan 31, 2001 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2000 | Supplement 21Efficacy (new indication or use) | Approved | |
| Oct 20, 2000 | Supplement 22Efficacy (new indication or use) | Approved | |
| Sep 29, 2000 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Nov 24, 1999 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Nov 24, 1999 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 1999 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jun 8, 1999 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Apr 25, 1997 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 25, 1997 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 1995 | Original applicationNew molecular entity · Priority review | Approved |
| FosamaxEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Alendronate Sodium | DiscontinuedReference drug |
| FosamaxEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Alendronate Sodium | DiscontinuedReference drug |
| FosamaxEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Alendronate Sodium | DiscontinuedReference drug |
| FosamaxEQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Alendronate Sodium | DiscontinuedReference drug |
| FosamaxEQ 70MG BASE · tablet;oral | Alendronate Sodium | RxReference drug |
| Feb 3, 2026 | Supplement 73Labeling · Standard review | Approved | |
| Aug 16, 2019 | Supplement 70Labeling · Standard review | Approved | |
| Nov 30, 2015 | Supplement 69Labeling · Standard review | Approved | |
| Jun 19, 2015 | Supplement 67Manufacturing · Priority review | Approved | None posted |
| Apr 8, 2015 | Supplement 68Labeling · Standard review | Approved | |
| Dec 23, 2013 | Supplement 66Labeling · Standard review | Approved | |
| Apr 19, 2013 | Supplement 65Labeling · Standard review | Approved | |
| Jun 27, 2012 | Supplement 62Labeling | Approved | |
| Feb 6, 2012 | Supplement 56Labeling · Standard review | Approved | |
| Jul 1, 2011 | Supplement 61REMS | Approved | |
| Jan 25, 2011 | Supplement 60REMS | Approved | |
| Mar 1, 2010 | Supplement 51Labeling · Standard review | Approved | |
| Mar 1, 2010 | Supplement 55Labeling · Standard review | Approved | |
| Mar 1, 2010 | Supplement 57Labeling · Standard review | Approved | |
| Oct 8, 2008 | Supplement 52Labeling · Standard review | Approved | |
| Dec 28, 2006 | Supplement 47Labeling · Standard review | Approved | |
| Dec 28, 2006 | Supplement 48Labeling · Standard review | Approved | |
| Dec 21, 2005 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Nov 2, 2005 | Supplement 46Labeling · Standard review | Approved | |
| Dec 1, 2004 | Supplement 43Labeling · Standard review | Approved | |
| Dec 1, 2004 | Supplement 44Labeling · Standard review | Approved | |
| Apr 27, 2004 | Supplement 30Labeling · Standard review | Approved | |
| Apr 16, 2004 | Supplement 41Efficacy (new indication or use) | Approved | |
| Feb 20, 2004 | Supplement 42Labeling · Standard review | Approved | |
| Sep 17, 2003 | Supplement 40Labeling · Standard review | Approved | |
| Mar 24, 2003 | Supplement 37Labeling · Standard review | Approved | |
| Sep 16, 2002 | Supplement 28Labeling · Standard review | Approved | |
| Aug 13, 2002 | Supplement 33Manufacturing · Priority review | Approved | |
| Aug 5, 2002 | Supplement 36Manufacturing · Priority review | Approved | |
| Jul 25, 2002 | Supplement 31Labeling · Standard review | Approved | |
| Nov 27, 2001 | Supplement 32Manufacturing · Priority review | Approved | |
| Jun 26, 2001 | Supplement 29Manufacturing · Priority review | Approved | |
| Jan 31, 2001 | Supplement 24Labeling · Standard review | Approved | |
| Jan 31, 2001 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2000 | Supplement 21Efficacy (new indication or use) | Approved | |
| Oct 20, 2000 | Supplement 22Efficacy (new indication or use) | Approved | |
| Sep 29, 2000 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Nov 24, 1999 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Nov 24, 1999 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Oct 19, 1999 | Supplement 16Manufacturing · Priority review | Approved | |
| Oct 19, 1999 | Supplement 20Manufacturing · Priority review | Approved | |
| Jun 16, 1999 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jun 8, 1999 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| May 28, 1999 | Supplement 19Manufacturing · Priority review | Approved | |
| Mar 19, 1999 | Supplement 14Labeling · Standard review | Approved | |
| May 12, 1998 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 27, 1998 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Apr 25, 1997 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 25, 1997 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 1997 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Dec 3, 1996 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 21, 1996 | Supplement 5Labeling | Approved | None posted |
| Oct 16, 1995 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 29, 1995 | 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
