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

McNeil loratadine

This article was originally published in The Tan Sheet

Executive Summary

J&J division will market OTC equivalent to Schering-Plough's Claritin under the brand name Proclir. On July 19, FDA deemed McNeil's NDA (021339) for loratadine tablets "approvable." Wyeth's NDA (021375) for Alavert, the equivalent to Claritin Reditabs, was pronounced "approvable" on July 3 (1"The Tan Sheet" July 22, 2002, In Brief). Schering filed patent infringement lawsuits against McNeil in December, Wyeth in January...

You may also be interested in...



Wyeth OTC loratadine “approvable”

FDA deems firm's application for Alavert, an OTC version of Schering-Plough's Claritin Reditabs (loratadine), approvable July 3. Alavert will employ CIMA Labs' DuraSolv technology; CIMA announced an exclusive license, supply agreement with Wyeth June 27 ("1The Tan Sheet" July 1, 2002, p. 4). Wyeth filed an NDA under section 505(b)(2) in January; McNeil also filed a 505(b)(2) application in November. Schering sued both companies for patent infringement 2("The Tan Sheet" Feb. 4, 2002, p. 3)...

Bayer Confident CureVac COVID Pact Will Be A Success

CEO Werner Baumann admits he was skeptical at first as to whether the German group had the necessary know-how to manufacture vaccines but the firm's expertise in the development of biotech products has strengthened his belief Bayer can deliver.

EMA Works On Defining Metadata From RWD Sources

As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.

Topics

UsernamePublicRestriction

Register

LL1135645

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