Ovidrel

For follicle stimulating hormones. BLA 21149, held by Emd Serono. Choriogonadotropin Alfa.

As of Nov 13, 2026, BLA 21149 (Ovidrel), held by Emd Serono, was first approved by FDA on Sep 20, 2000, with 18 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2000
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients 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 19 submissions below

Date	Submission	Status	Documents
Sep 20, 2000	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ovidrel0.25MG/VIAL · injectable;injection	Choriogonadotropin Alfa	Discontinued
OvidrelEQ 0.25MG /0.5ML · injectable;subcutaneous	Choriogonadotropin Alfa	Rx

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 30, 2015	Supplement 40Manufacturing · Standard review	Approved	None posted
Dec 11, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Dec 19, 2013	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 11, 2013	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 9, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 11, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 5, 2013	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 31, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 31, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 15, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 15, 2013	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 13, 2012	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 10, 2012	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 2, 2010	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 30, 2007	Supplement 13Labeling · Standard review	Approved	Letter Label
Jul 14, 2003	Supplement 6Labeling · Standard review	Approved	Letter
May 15, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 20, 2000	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: BLA 21149
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