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

Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study

Executive Summary

HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.

You may also be interested in...



Keeping Track: Longer US FDA Reviews For Tislelizumab, Toripalimab, Olipudase; Perrigo Wants OC To Go OTC

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application

Perrigo's HRA Pharma submits to FDA on 11 July an NDA by for OTC 0.075-mg norgestrel, branded Opill, The same formulation previously was available Rx 30 years. 

AMA Shares OTC Birth Control Diagnosis With FDA

American College of Obstetricians and Gynecologists proposed amending existing AMA policy in anticipation of Perrigo’s HRA business submitting NDA to FDA for OTC switch of progestin-only daily oral contraceptive the end of 2022.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS123344

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