Pink Sheet 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
UsernamePublicRestriction

OTC clemastine data for common cold can be generalized to children -- FDA advisory cmte..

This article was originally published in The Tan Sheet

Executive Summary

OTC CLEMASTINE DATA CAN BE GENERALIZED TO PEDIATRIC POPULATIONS for treatment of the common cold, FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees agreed at a Nov. 16 joint meeting in Rockville, MD. The committees voted 12-3 that the common cold is sufficiently similar in the adult and pediatric populations to allow the results of Sandoz' two randomized, double-blind, placebo-controlled trials to be extrapolated to children six to 12.
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS084535

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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