Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Yasmin review extension

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's user fee deadline for a low-dose version of Schering AG's oral contraceptive Yasmin (ethinyl estradiol/drospirenone) is Nov. 16 following a three-month review extension. "According to the FDA's written notification to [U.S. subsidiary] Berlex…the extension 'will provide time for a full review' of the application," Schering AG reported July 19. The firm said it "is confident in a 2005 launch" for the product, which contains 0.02 mg of estradiol compared to 0.03 mg in currently available Yasmin. A 2004 launch was projected at the time of the October 2003 filing...





Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts