FDA Approves Ferring Pharmaceuticals' Menopur And Bravelle For Fertility
By Cyndi Root
Ferring Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved a combination of Menopur and Bravelle. The combination of drugs in a single injection is indicated for fertility. Approval was based on a pharmacodynamics study that showed the combination treatment did not interfere with drug delivery. Nick Hart, Ferring’s Business Unit Head for U.S. Reproductive Health said, “Ferring is excited to provide an IVF treatment option that requires fewer injections. We are pleased with the FDA’s response and look forward to offering physicians and patients the ability for customization and a simplified treatment protocol.”
Infertility
Infertility is diagnosed after a year of unsuccessful pregnancy attempts. Stillbirths and miscarriages are also grouped under infertility. Men and women can opt for drugs that treat infertility. With treatment, many are able to conceive and bring a child to full term.
Menopur
Menopur is a hormone treatment. Administered subcutaneously, Menopur stimulates the follicles and ovaries to produce eggs. The treatment seeks to produce many mature eggs without over stimulating the ovaries. Women with ovarian failure, endocrinopathies, tumors, or bleeding are not suitable for the medication. Serious side effects include pulmonary and thromboembolic conditions. Women may have multiple pregnancies and fetuses may abort spontaneously or have malformations.
Bravelle
Bravelle is a medicine that contains hormones. Like Menopur, it stimulates the ovaries to make eggs. It is administered subcutaneously and intramuscularly. Bravelle is often administered with Human Chorionic Gonadotropin (HCG). Patients who have previously received pituitary suppression benefit most from the drug.
Injection System
The FDA received a Premarket Summary from Medimop Medical Projects of Israel for the injection system to be used by Ferring for both drugs. The device is a single use sterile device used on a single patient in one procedure. The device t enables reconstitution or transfer of Bravelle and Menopur into an injection syringe.
About Ferring
Ferring Pharmaceuticals is a privately owned pharmaceutical company with international interests. Its focus is on reproductive health, orthopedics, gynecology, and gastroenterology. The company recently purchased 25 acres in Parsippany, NY, which will integrate manufacturing, marketing, and administration.