Helps diagnose cause of infertility. BLA 21211, held by Organon USA LLC. Follitropin Alfa/Beta.
As of Nov 13, 2026, BLA 21211 (Follistim Aq), held by Organon USA LLC, was first approved by FDA on Mar 23, 2004, with 11 approved supplements and 0 published complete response letters.
FOLLISTIM AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle In Men for: Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2011 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jun 28, 2010 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Follistim Aq300 IU/0.36ML · injectable;subcutaneous | Follitropin Alfa/Beta | Rx |
| Follistim Aq600 IU/0.72ML · injectable;subcutaneous | Follitropin Alfa/Beta | Rx |
| Follistim Aq150 IU/0.18ML · injectable;subcutaneous | Follitropin Alfa/Beta | Discontinued |
| Follistim Aq900 IU/1.08ML · injectable;subcutaneous | Follitropin Alfa/Beta | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2026 | Supplement 47Labeling · Standard review | Approved | |
| Feb 7, 2024 | Supplement 37Labeling · Standard review | Approved | |
| Mar 21, 2023 | Supplement 42Labeling · Standard review | Approved | |
| Mar 21, 2023 | Supplement 36Labeling · Standard review | Approved | |
| Mar 21, 2023 | Supplement 27Labeling · Standard review | Approved | |
| Dec 15, 2016 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 15, 2016 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 9, 2015 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 22, 2011 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jun 28, 2010 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 11, 2005 | Supplement 2Manufacturing · Standard review | Approved | |
| Mar 23, 2004 | Original applicationNew dosage form · 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
