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Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health) | Family Medicine | Urology

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Bravelle (urofollitropin for injection, purified)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Ferring Pharmaceuticals
Approval Status: Approved May 2002
Treatment Area: Ovulation induction / infertility

General Information

Bravelle, approved in May 2002 for the treatment of infertility, is a highly purified, human-derived follicle-stimulating hormone (hFSH) indicated for ovulation induction following pituitary suppression. It is used in conjuction with human chorionic gonadotropin.

Bravelle is available for both subcutaneous and intramuscular injection.

Clinical Results

Brevelle was evaluated in a prospective, parallel group, multicenter trial involving 111 oligo-anovulatory subjects undergoing ovulation induction. The trial compared Bravelle to follitropin beta, a recombinant FSH. Subjects first underwent pituitary suppression with a GnRH agonist and were then randomized into three treatment groups: Bravelle subcutaneous (SC), Bravelle intramuscular (IM), and follitropin beta SC. Results of this clinical trial showed no significant differences in safety and efficacy between the treatment groups.

Side Effects

Adverse reactions included ovarian hyperstimulation syndrome (OHSS), with or without pulmonary or vascular complications, which occurred in 8.2% of subjects receiving Brevelle.

Additional Information

For more information about Bravelle, please visit the Ferring Pharmaceuticals web site at: www.ferringusa.com.