HBW Insight 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

Plan B One-Step OTC Proposal Leaves Plaintiffs, Judge Korman Wary

This article was originally published in The Pink Sheet Daily

Executive Summary

The Center for Reproductive Rights and other plaintiffs suing FDA say the agency’s plan to approve only Teva’s Plan B One-Step for universal OTC sales, but not less-expensive generic emergency contraceptives, would not provide sufficient access for all women.

You may also be interested in...



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.

With Exclusivity For Single-Dose Plan B, Teva Stays One Step Up On Generics

Teva Pharmaceutical Industries likely will gain another three years of exclusivity in the branded nonprescription emergency contraceptive market with FDA's approval of a revised dosage of Plan B

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.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS124332

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