TheraRadar
Data updated: May 26, 2026

GONAL-F RFF (follitropin alfa/beta)

Women's Health Approved 2004-03-25

GONAL-F RFF is indicated for the treatment of Infertility.

Source: FDA Label • EMD SERONO
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-03-25
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

EMD SERONO
Active Ingredient: FOLLITROPIN ALFA/BETA

GONAL-F RFF Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 2004 to 2023
Nov 2023 SUPPL
Label · Labeling
FDA Letter Label
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label
Feb 2016 SUPPL
Mfg · Manufacturing (CMC)

What GONAL-F RFF Treats

1 indications

GONAL-F RFF is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Infertility
Source: FDA Label

GONAL-F RFF Target & Pathway

Pro

Target

FSHR ()

GONAL-F RFF Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

EXEM FOAM KIT
GISKIT
2019 1 indic.
MENOPUR
FERRING
2004 1 indic.
Unlock 2 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to GONAL-F RFF

3 of 7

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CRINONE
PROGESTERONE
1 shared
WATSON LABS INC
Shared indications:
Infertility
ENDOMETRIN
PROGESTERONE
1 shared
FERRING
Shared indications:
Infertility
EXEM FOAM KIT
AIR POLYMER-TYPE A
1 shared
GISKIT
Shared indications:
Infertility
View all 7 similar drugs Pro
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

GONAL-F RFF FDA Label Details

Indications & Usage

FDA Label (PDF)

GONAL-F RFF is indicated for the treatment of Infertility.

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Data Sources

FDA Approval: BLA021765 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.