FDA approves Bravelle - a human-derived follicle-stimulating hormone.(Food and Drug Administration)(Ferring Pharmaceuticals)(infertility treatment)(Brief Article)

2002 JUN 13 - (NewsRx.com & NewsRx.net) -- Ferring Pharmaceuticals, a world leader in naturally occurring protein hormones, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Bravelle (urofollitropin for injection, purified), a highly purified, human-derived follicle-stimulating hormone (hFSH) for the treatment of infertility. Bravelle, in conjunction with human chorionic gonadotropin, is indicated for ovulation induction following pituitary suppression.

"With the introduction of Bravelle, Ferring has expanded its family of human-derived hormones to include a highly purified, well-tolerated hFSH with proven efficacy in ovulation induction, a critical step in many infertility treatment protocols," said Wayne Anderson, president of Ferring Pharmaceuticals. "Based on the fact that recombinant technology has shown no meaningful advantage in either efficacy or safety in the clinic, Ferring remains committed to the development of human-derived products in order to seek improvements in ovarian stimulation protocols. Ferring has submitted an application to the FDA seeking additional indications for Bravelle in infertility treatment. This application, which is supported by additional clinical studies, brings the total number of patients studied to 577. This application is currently under review by the FDA."

Bravelle was compared with follitropin beta, a recombinant FSH, in a ...