BLA 21273, held by Organon USA Inc. Follitropin Alfa/Beta.
As of Nov 13, 2026, BLA 21273 (Follistim Aq), held by Organon USA Inc, was first approved by FDA on Aug 26, 2005, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2010 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 26, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Follistim Aq75 IU/0.5ML · injectable;subcutaneous | Follitropin Alfa/Beta | Discontinued |
| Follistim Aq150 IU/0.5ML · injectable;subcutaneous | Follitropin Alfa/Beta | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2015 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 19, 2013 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 28, 2010 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 24, 2008 | Supplement 3Manufacturing | Approved | |
| Aug 8, 2006 | Supplement 1Manufacturing | Approved | None posted |
| Aug 26, 2005 | Original applicationNew dosage form · Standard review | Approved |
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
