Treats HIV and wasting or cachexia. BLA 20604, held by Emd Serono. Somatropin.
As of Nov 13, 2026, BLA 20604 (Serostim, Serostim Lq), held by Emd Serono, was first approved by FDA on Aug 23, 1996, with 51 approved supplements and 0 published complete response letters.
SEROSTIM (somatropin) is indicated for the treatment of adults with HIV and wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2007 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Aug 29, 2003 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Aug 23, 1996 | Original applicationNew formulation or manufacturer · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Serostim6MG/VIAL · injectable;injection | Somatropin | Rx |
| Serostim5MG/VIAL · injectable;injection | Somatropin | Rx |
| Serostim4MG/VIAL · injectable;injection | Somatropin | Rx |
| Serostim8.8MG/VIAL · injectable;injection | Somatropin | Discontinued |
| Serostim Lq6MG/0.5ML (6MG/0.5ML) · injectable;subcutaneous | Somatropin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 2026 | Supplement 104Labeling · Standard review | Approved | |
| May 24, 2017 | Supplement 74Labeling · Standard review | Approved | |
| May 9, 2017 | Supplement 93Labeling · Standard review | Approved | |
| Dec 13, 2016 | Supplement 89Labeling · Standard review | Approved | |
| Dec 13, 2016 | Supplement 90Labeling · Standard review | Approved | |
| Sep 30, 2014 | Supplement 81Manufacturing · Priority review | Approved | None posted |
| Sep 17, 2014 | Supplement 80Manufacturing · Priority review | Approved | None posted |
| Aug 11, 2014 | Supplement 82Manufacturing · Priority review | Approved | None posted |
| Jun 18, 2014 | Supplement 78Labeling | Approved | |
| Dec 12, 2013 | Supplement 76Manufacturing · Priority review | Approved | None posted |
| Dec 11, 2013 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Apr 5, 2013 | Supplement 73Manufacturing · Priority review | Approved | None posted |
| Feb 28, 2013 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Feb 15, 2013 | Supplement 68Manufacturing · Priority review | Approved | None posted |
| Feb 8, 2013 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Jan 31, 2013 | Supplement 67Manufacturing · Priority review | Approved | None posted |
| Nov 20, 2012 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Apr 3, 2012 | Supplement 49Labeling · Standard review | Approved | |
| Aug 31, 2009 | Supplement 48Labeling · Standard review | Approved | |
| Aug 30, 2007 | Supplement 44Labeling · Standard review | Approved | |
| Jul 13, 2007 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Nov 27, 2006 | Supplement 35Manufacturing | Approved | |
| Sep 21, 2006 | Supplement 34Manufacturing · Priority review | Approved | |
| Aug 24, 2005 | Supplement 31Labeling · Standard review | Approved | |
| Feb 11, 2005 | Supplement 29Manufacturing · Priority review | Approved | |
| Jul 9, 2004 | Supplement 30Manufacturing · Priority review | Approved | |
| Dec 1, 2003 | Supplement 26Labeling · Standard review | Approved | |
| Aug 29, 2003 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Dec 31, 2002 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Dec 20, 2002 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Oct 17, 2002 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Sep 6, 2002 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Dec 3, 2001 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Nov 19, 2001 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Sep 6, 2001 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jul 19, 2001 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jun 13, 2001 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 3, 2001 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Oct 27, 2000 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 18, 2000 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Aug 17, 2000 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 19, 2000 | Supplement 12Manufacturing · Priority review | Approved | |
| Jul 17, 2000 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 11, 2000 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Apr 4, 2000 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 28, 2000 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1998 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1998 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 21, 1998 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jan 16, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 25, 1997 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 23, 1996 | Original applicationNew formulation or manufacturer · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
