HBW Insight 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

Firms Explore First-In-Class Switches With NSURE Still In Limbo

This article was originally published in The Tan Sheet

Executive Summary

Firms are moving forward with potential first-in-class switches for chronic conditions, says Concentrics Research CEO Julie Aker. Meanwhile, FDA’s NSURE initiative offers “a lot of opportunity,” but “is still very conceptual,” the agency says.

You may also be interested in...



In Brief: Furness in new CDER role; Oxytrol for Women at retail; advisories on drug-tainted sex enhancers; senators want energy drink restrictions

Furness takes on new CDER role; Merck’s Oxytrol OTC arrives at retail; FDA issues advisory on drug-tainted sex enhancers; senators want energy drink restrictions; more news In Brief.

FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney

Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.

Merck’s Oxytrol Could Be OTC Trailblazer For Chronic Conditions

Merck’s Oxytrol for Women has the opportunity to “create the market” for OTC overactive bladder drugs, as well as encourage other switches for chronic, progressive conditions, marketing consultant Joe McGovern says. The transdermal patch product is slated to launch in September.

Topics

Related Companies

UsernamePublicRestriction

Register

RS124046

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