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

Formycon And Bioeq Offer Ranibizumab Update

Formycon and partner Bioeq have offered further details on timing for the submission of their FYB201 proposed ranibizumab biosimilar version of Lucentis in Europe, the US and elsewhere.

Oxular Sets Out Eye Disease Plans Armed With $37m

The fresh cash injection will fund Phase II studies evaluating the UK firm's 12-month treatment for diabetic macular edema.

UsernamePublicRestriction

Register

LL1129949

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