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

Forced OTC switch issue returns to FDA

Executive Summary

A new citizen's petition asks FDA to switch two antihistamines, Sanofi-Aventis' Allegra and Pfizer's Zyrtec, to OTC status. The petition, filed March 12 by attorney Joel Stocker of Greenberg Traurig, makes the case that the "positive OTC experience" of Schering-Plough's Claritin "has made the case to switch [Allegra and Zyrtec] even more compelling." Schering initially fought a Wellpoint petition to force an OTC switch of Claritin (along with Allegra and Zyrtec), but later filed a sNDA to switch Claritin (1"The Pink Sheet" Dec. 2, 2002, p. 7). FDA previously declined to act on the petitions for Allegra and Zyrtec...

You may also be interested in...



Schering OTC Claritin Will Launch In December Without Rx Transition Period

Schering-Plough prescription Claritin availability will not overlap with OTC loratadine once the switched drug becomes available in December

FDA To Ramp Up ASCA Pilot In 2021

A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.

Scotland's MGB Plots Phase III For Promising Antibacterial

With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.

UsernamePublicRestriction

Register

LL035386

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