Gonal-F Rff Redi-Ject

BLA 21684, held by Emd Serono. Follitropin Alfa/Beta.

As of Nov 14, 2026, BLA 21684 (Gonal-F Rff Redi-Ject), held by Emd Serono, was first approved by FDA on May 25, 2004, with 14 approved supplements and 0 published complete response letters.

First approved: May 25, 2004
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 25, 2004	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

4 strengths and forms


Gonal-F Rff Redi-Ject300 IU/0.5ML · injectable;subcutaneous	Follitropin Alfa/Beta	Rx
Gonal-F Rff Redi-Ject450 IU/0.75ML · injectable;subcutaneous	Follitropin Alfa/Beta	Rx
Gonal-F Rff Redi-Ject900 IU/1.5ML · injectable;subcutaneous	Follitropin Alfa/Beta	Rx
Gonal-F Rff Redi-Ject150 IU/0.25ML · injectable;subcutaneous	Follitropin Alfa/Beta	Rx

All 15 submissions, including labeling and manufacturing supplements


May 13, 2024	Supplement 51Labeling · Standard review	Approved	Label Letter
May 13, 2024	Supplement 50Labeling · Standard review	Approved	Label Letter
Nov 6, 2017	Supplement 38Manufacturing	Approved	None posted
Oct 16, 2013	Supplement 36Manufacturing	Approved	Label
Apr 4, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 19, 2013	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 14, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 6, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 31, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 23, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 11, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 18, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 6, 2007	Supplement 8Manufacturing	Approved	Letter
May 25, 2004	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: BLA 21684
Drugs@FDA: Overview at FDA
Company: EMD Serono, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters