Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Additional Seasonique Data Not Required To Support Extended-Cycle Approval, Barr Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The firm anticipates approval of the 91-day cycle contraceptive in "a couple months."

You may also be interested in...



Barr To Focus On Seasonique After Dropping Lo Seasonale

Company withdraws its application for the low-dose extended cycle contraceptive in advance of the user fee date.

Barr To Focus On Seasonique After Dropping Lo Seasonale

Company withdraws its application for the low-dose extended cycle contraceptive in advance of the user fee date.

Barr's Seasonique Is "Approvable" Pending Data On The Contraceptive's Regimen

The firm is seeking a meeting with FDA to discuss use of results from ongoing studies of the extended-regimen oral contraceptive.

Topics

UsernamePublicRestriction

Register

OM006051

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel