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

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

UsernamePublicRestriction

Register

PS122308

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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