Bravelle

BLA 21289, held by Ferring. Urofollitropin.

As of Nov 13, 2026, BLA 21289 (Bravelle), held by Ferring, was first approved by FDA on May 6, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: May 6, 2002
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 19, 2014	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 6, 2002	Original applicationNew dosage form · Standard review	Approved	Review Other Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bravelle75 IU/VIAL · injectable;intramuscular, subcutaneous	Urofollitropin	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 27, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 27, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 11, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 19, 2014	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 14, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
May 6, 2002	Original applicationNew dosage form · Standard review	Approved	Review Other Label Letter

Identifiers

Application: BLA 21289
Drugs@FDA: Overview at FDA
Company: Ferring Pharmaceuticals

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