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


Revised Suit Seeks Full OTC Status For Plan B One-Step And Generics

This article was originally published in The Tan Sheet

Executive Summary

The Center for Reproductive Rights amends its suit against FDA to compel universal OTC access to levonorgestrel emergency contraceptives. The advocacy group adds HHS Secretary Kathleen Sebelius as a defendant after her recent decision to overrule FDA’s approval of OTC sales for Plan B One-Step.

You may also be interested in...

Updated Plan B Lawsuit Could Expand EC Switch Targets

The Center for Reproductive Rights plans to revise its 2005 complaint against FDA seeking OTC access to emergency contraceptives. In addition to adding HHS Secretary Sebelius as a defendant, CRR likely will ask for OTC sales of second-generation Plan B One-Step since the original product is available only as generics.

Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle

HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.

NaZura’s Lovidia Weight-Loss Supplement Strategy Focused On Brand Building

NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.


Related Companies




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