GONAL-F RFF REDI-JECT
GONAL-f RFF Redi-ject is a gonadotropin-containing auto-injection device indicated for the treatment of female infertility. It is used to induce ovulation and pregnancy in oligo-anovulatory women whose infertility is functional and not due to primary ovarian failure. The medication is also indicated for the development of multiple follicles in ovulatory women participating in an Assisted Reproductive Technology (ART) cycle. Prior to initiation, patients must undergo evaluation to exclude primary ovarian failure and confirm the status of their male partner and tubal patency.
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.
Details
- Status
- Prescription
- First Approved
- 2004-05-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
GONAL-F RFF REDI-JECT Approval History
What GONAL-F RFF REDI-JECT Treats
1 indicationsGONAL-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
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Active Pipeline
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Trial Timeline
Full development history with FDA approval milestones
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
ProIndications & Usage
FDA Label (PDF)GONAL-f ® RFF Redi-ject ® is a prefilled gonadotropin-containing auto-injection device indicated for: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle 1.1 Induction of Ovulation and Pregnancy in Oligo-Anovulatory Women in whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure. Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a compl...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.