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

Merck Silence On OTC Singulair Speaks Volumes On Switch Outlook

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck’s silence on an OTC version of Singulair is a sign of the relatively “quiet” 2015 switch market despite the call for novel switches, particularly to treat chronic conditions, from FDA’s Nonprescription Drug Safe Use Regulatory Expansion Initiative.

You may also be interested in...



US FDA Beats Clock On NDAC Charter Renewal

Give agency credit for beating the expiration date after missing it in previous renewals.

Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'

"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.

First-In-Class Nasacort OTC Also Originates ‘Children’s’ Label

Sanofi introduces Children’s Nasacort Allergy 24HR in the same formulation and dosage as the original OTC switch, but with “children’s” added to the package after approval by FDA. The firm promotes the product as the “first and only” 24-hour multi-symptom nasal allergy spray available OTC for children ages 2 and up.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS123541

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