Saizen

BLA 19764, held by Emd Serono. Somatropin.

As of Nov 14, 2026, BLA 19764 (Saizen), held by Emd Serono, was first approved by FDA on Oct 8, 1996, with 56 approved supplements and 0 published complete response letters.

First approved: Oct 8, 1996
Review: Standard
Supplements approved: 56
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 57 submissions below


Nov 1, 2004	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 8, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Saizen6MG/VIAL · injectable;injection	Somatropin	Discontinued
Saizen5MG/VIAL · injectable;injection	Somatropin	Rx
Saizen8.8MG/VIAL · injectable;injection	Somatropin	Rx
Saizen4MG/VIAL · injectable;injection	Somatropin	Discontinued

All 57 submissions, including labeling and manufacturing supplements


May 8, 2017	Supplement 86Labeling · Standard review	Approved	Letter Label Other
Jan 17, 2017	Supplement 79Manufacturing · Standard review	Approved	Label
Dec 13, 2016	Supplement 83Labeling · Standard review	Approved	Letter Label
Apr 21, 2016	Supplement 80Manufacturing · Standard review	Approved	Other
Jun 12, 2015	Supplement 78Manufacturing · Standard review	Approved	None posted
Jun 11, 2015	Supplement 62Manufacturing · Standard review	Approved	None posted
Mar 3, 2015	Supplement 77Manufacturing · Standard review	Approved	None posted
Feb 16, 2015	Supplement 76Manufacturing · Standard review	Approved	None posted
Sep 30, 2014	Supplement 73Manufacturing · Standard review	Approved	None posted
Aug 11, 2014	Supplement 74Manufacturing · Standard review	Approved	None posted
Jun 18, 2014	Supplement 72Labeling	Approved	Letter Label
Dec 12, 2013	Supplement 70Manufacturing · Standard review	Approved	None posted
Nov 18, 2013	Supplement 71Manufacturing · Standard review	Approved	None posted
Nov 13, 2013	Supplement 59Manufacturing · Standard review	Approved	None posted
Apr 5, 2013	Supplement 69Manufacturing · Standard review	Approved	None posted
Feb 20, 2013	Supplement 67Manufacturing · Standard review	Approved	None posted
Feb 15, 2013	Supplement 66Manufacturing · Standard review	Approved	None posted
Feb 15, 2013	Supplement 65Manufacturing · Standard review	Approved	None posted
Feb 13, 2013	Supplement 63Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Supplement 61Manufacturing · Standard review	Approved	None posted
Feb 7, 2013	Supplement 60Manufacturing · Standard review	Approved	None posted
Jan 31, 2013	Supplement 64Manufacturing · Standard review	Approved	None posted
Jan 19, 2013	Supplement 58Manufacturing · Standard review	Approved	None posted
Jan 19, 2013	Supplement 57Manufacturing · Standard review	Approved	None posted
Jan 19, 2013	Supplement 56Manufacturing · Standard review	Approved	None posted
Jan 18, 2013	Supplement 54Manufacturing · Standard review	Approved	None posted
Jan 11, 2013	Supplement 53Manufacturing · Standard review	Approved	None posted
Jan 11, 2013	Supplement 52Manufacturing · Standard review	Approved	None posted
Apr 3, 2012	Supplement 49Labeling	Approved	Letter Label
Oct 31, 2007	Supplement 35Manufacturing	Approved	Label Letter
Aug 27, 2007	Supplement 39Labeling · Standard review	Approved	Letter Label
Aug 22, 2007	Supplement 37Labeling · Standard review	Approved	Letter Label
Mar 5, 2007	Supplement 34Labeling · Standard review	Approved	Label Letter
Jan 16, 2007	Supplement 30Manufacturing	Approved	Label Letter
Nov 1, 2004	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 9, 2004	Supplement 25Manufacturing · Standard review	Approved	Letter Label
Jul 1, 2003	Supplement 23Labeling · Standard review	Approved	Letter Label
Dec 31, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 20, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 17, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 6, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 3, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 19, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
May 3, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 29, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 17, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 26, 2000	Supplement 9Labeling · Standard review	Approved	None posted
Jul 19, 2000	Supplement 11Manufacturing · Standard review	Approved	Review
Jun 7, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 11, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 4, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Mar 28, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 11, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 9, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 21, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 9, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Oct 8, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Show all 57

Identifiers

Application: BLA 19764
Drugs@FDA: Overview at FDA
Company: EMD Serono, Inc.

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