HBW Insight 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

Wyeth OTC loratadine

This article was originally published in The Tan Sheet

Executive Summary

Company says it holds "first to file" ANDA status for orally disintegrating loratadine (Schering's Claritin Reditabs). Wyeth also has a pending 505(b)(2) application for OTC sale of the product. Firm recently told analysts Alavert launch would not be sidelined for six months by exclusivity issues (1"The Tan Sheet" Oct. 28, 2002, p. 4)...

You may also be interested in...



Andrx loratadine

Generics maker receives tentative FDA approval of ANDA (75-990) for orally disintegrating loratadine tablets (Schering's Claritin Reditabs) Nov. 15. Andrx previously was granted tentative approval for 24-hour loratadine/ pseudoephedrine combination (Claritin-D 24-Hour), for which it holds "first-to-file" status. Wyeth has said it holds FTF ANDA status for orally disintegrating loratadine (1"The Tan Sheet" Nov. 4, 2002, In Brief). FDA's target action date on Schering's switch NDAs for Claritin is Nov. 28; loratadine compound patent exclusivity expires Dec. 19...

Wyeth OTC Loratadine Launch Unaffected By ANDA Exclusivity Issues – Exec

Wyeth Consumer Healthcare, which reported sluggish third quarter sales, could experience a big revenue boost late in Q4 if its plans to launch OTC loratadine upon expiration of Schering-Plough's patent remain on track

Henlius Has Denosumab Application Accepted In China

Shanghai Henlius Biotech has announced that China’s NMPA has accepted the firm’s filing for its HLX14 denosumab biosimilar. Meanwhile, the company has also announced dosing the first patient in a Phase II clinical trial of its novel HLX10 anti-PD-1 monoclonal antibody.

Topics

UsernamePublicRestriction

Register

RS131033

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