Bravelle® (urofollitropin)

BL 021484

Bravelle® (urofollitropin)

BL 021484

U.S. License Holder:

Ferring

Date of License:

December-19-2002

Last Update:

Feb-15-2025

approved_indications FDA-Approved Indications

BRAVELLE (urofollitropin) is a gonadotropin indicated for:

Induction of ovulation in women who have previously received pituitary suppression - intramuscular and subcutaneous administration;

Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression.

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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