Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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)...

US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising

US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS094366

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