Quick answers
- What is Follitropin used for?
- The FDA-approved label (Follistim AQ, Organon LLC, May 26, 2026) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Follitropin have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Follitropin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Follitropin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Follitropin?
- 2 companies list prescription products of Follitropin in the FDA NDC Directory, including EMD Serono, Inc. and Organon LLC.
What Follitropin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Follistim AQ, Organon LLC, effective May 26, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Gonal-F Rff Redi-Ject, Follistim Aq |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- EMD Serono, Inc.3 products
- Organon LLC3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021211 FOLLISTIM AQ | Organon USA LLC | March 23, 2004 | 11, latest February 24, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| BLA021684 GONAL-F RFF REDI-JECT | Emd Serono | May 25, 2004 | 14, latest May 13, 2024 2024: Labeling · 2024: Labeling · 2017: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Follistim AQ, Organon LLC, effective May 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →