Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Court Ruling Compels Plan B One-Step And Generics Over The Counter

This article was originally published in The Tan Sheet

Executive Summary

Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to levonorgestrel-based emergency contraceptives within 30 days.

You may also be interested in...



Pharma Firm ISO OTC Switch Partner; NDA Experience, Resources Needed

Success in OTC switches can hinge on finding the right partner, say switch consultants during a CHPA webinar. Due diligence in negotiations can help determine if a potential partner is the right fit for the time- and labor-intensive processes.

Pharma Firm ISO OTC Switch Partner; NDA Experience, Resources Needed

Success in OTC switches can hinge on finding the right partner, say switch consultants during a CHPA webinar. Due diligence in negotiations can help determine if a potential partner is the right fit for the time- and labor-intensive processes.

Judge Likely To Order Lower Age Restriction For Emergency Contraceptives

A federal judge seems inclined to order FDA to make emergency contraceptives available OTC to women younger than 17, but he did not say whether the use would be limited to Teva’s Plan B One-Step, or would include all nonprescription levonorgestrel products.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS106319

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