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

‘Storm Of Change’ Could Propel Industry On Making Daily Oral Contraceptive Available OTC In US

Executive Summary

“It’s going to be industry people like me that have to make a decision that we're going to spend the time, we're going to spend the money to work with FDA for the many years it takes generally speaking to get these things approved,” says Femasys CEO Kathy Lee-Sepsick.

You may also be interested in...



Will Influences Behind US FDA's Delayed Approval For OTC Plan B Also Shadow ‘Plan A’ Switch?

FDA history with emergency contraceptives and opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, Valley Surgical Clinics founder and advocate for making more drugs available OTC, the agency will approve HRA Pharma's NDA for OTC 0.075-mg norgestrel.

Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?

OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.

Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers

“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

RS152697

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