SERONO'S METRODIN IS APPROVED FOR SECOND-LINE TREATMENT OF INFERTILITY in women with polycystic ovarian syndrome. The package insert for Metrodin (human follicle stimulating hormone), approved by FDA on Sept. 18, states: "Metrodin and hCG [human chorionic gonadotropin] given in a sequential manner are indicated for the induction of ovulation in patients with polycystic ovarian disease who have an elevated LH/FSH ratio and who have failed to respond to adequate clomiphene citrate therapy." Patients must meet the following criteria before going on Metrodin treatment: a gynecologic and endocrinologic evaluation, exclusion of primary ovarian failure or early pregnancy, cervical dilation and curettage, and evaluation of the husband's fertility potential. Adverse reactions with Metrodin have occurred in "approximately 1 in 10" patients; the most common reactions are hyperstimulation syndrome, ovarian enlargement, abdominal pain, and rash or swelling at the site of injection, the insert said. FDA classified Medtrodin as a 2 C product (a new salt or esther representing little or no therapeutic gain). In a press release, Serono maintained that Metrodin is the first product for treating infertility approved by the FDA in five years. Metrodin will become available to wholesalers on Nov. 1 at a price of $35.20 per amp.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
