Active substance
Follitropin alfa beta
- US FDA 9
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| GONAL-F | 1,050 IU/VIAL; 450 IU/VIAL | injectable · subcutaneous | EMD SERONO | Prescription | 29 Sep 1997 |
| FOLLISTIM AQ | 300 IU/0.36ML; 600 IU/0.72ML; 900 IU/1.08ML | injectable · subcutaneous | ORGANON USA LLC | Prescription | 23 Mar 2004 |
| GONAL-F RFF | 75 IU/VIAL | injectable · subcutaneous | EMD SERONO | Prescription | 25 Mar 2004 |
| GONAL-F RFF REDI-JECT | 300 IU/0.5ML; 450 IU/0.75ML; 900 IU/1.5ML; 150 IU/0.25ML | injectable · subcutaneous | EMD SERONO | Prescription | 25 May 2004 |
| GONAL-F | 75 IU/VIAL; 150 IU/VIAL; 37.5 IU/VIAL | injectable · subcutaneous | EMD SERONO | Discontinued | 29 Sep 1997 |
| FOLLISTIM | 75 IU/VIAL; 150 IU/VIAL | injectable · intramuscular, subcutaneous | ORGANON USA INC | Discontinued | 29 Sep 1997 |
| FOLLISTIM AQ | 150 IU/0.18ML | injectable · subcutaneous | ORGANON USA LLC | Discontinued | 23 Mar 2004 |
| GONAL-F | 37.5 IU/VIAL; 150 IU/VIAL | injectable · subcutaneous | EMD SERONO | Discontinued | 25 Mar 2004 |
| FOLLISTIM AQ | 75 IU/0.5ML; 150 IU/0.5ML | injectable · subcutaneous | ORGANON USA INC | Discontinued | 26 Aug 2005 |
Safety signals and safety-related labeling changes
- US FDA 24 Feb 2026 FOLLISTIM AQ — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 May 2024 GONAL-F RFF REDI-JECT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 31 Dec 2020 GONAL-F — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 31 Dec 2020 GONAL-F RFF — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.