TheraRadar
Data updated: May 26, 2026

GONAL-F RFF REDI-JECT (follitropin alfa/beta)

Women's Health Approved 2004-05-25

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

Source: FDA Label • EMD SERONO • Gonadotropin
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How GONAL-F RFF REDI-JECT Works

The active component, follicle stimulating hormone (FSH), is required for normal follicular growth, maturation, and gonadal steroid production. GONAL-f RFF Redi-ject stimulates ovarian follicular growth in women who do not have primary ovarian failure, determining the timing and number of follicles that reach maturity. To complete the final phase of follicle maturation and induce rupture, human chorionic gonadotropin (hCG) must be administered following treatment. There is inter-woman variability in response to the administration of this hormone.

Source: FDA Label
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-05-25
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

EMD SERONO
Active Ingredient: FOLLITROPIN ALFA/BETA

GONAL-F RFF REDI-JECT 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
60 FDA actions from 2004 to 2024
May 2024 SUPPL
Label · Labeling
FDA Letter Label
Nov 2017 SUPPL
Mfg · Manufacturing (CMC)
Oct 2013 SUPPL
Mfg · Manufacturing (CMC)
Label

What GONAL-F RFF REDI-JECT Treats

1 indications

GONAL-F RFF REDI-JECT 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 REDI-JECT 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.
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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 REDI-JECT

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FERRING
Shared indications:
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EXEM FOAM KIT
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Shared indications:
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Key Completed Trials

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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 REDI-JECT FDA Label Details

Indications & Usage

FDA Label (PDF)

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

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Data Sources

FDA Approval: BLA021684 → Label: DailyMed → Trials: ClinicalTrials.gov →

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