Pink Sheet is part of the Business Intelligence Division 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


Biovail citalopram ODT approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biovail's orally disintegrating tablet formulation of Forest's antidepressant Celexa (citalopram) clears FDA Dec. 20 under the 505(b)(2) pathway. The product, which currently has no trade name, had been "approvable" since February 2005. Biovail will have to submit an sNDA if it decides to market citalopram ODT under a brand name. The sponsor has pointed to the formulation's greater prescribing flexibility as an advantage (1Pharmaceutical Approvals Monthly July 2004, In Brief)...

Related Content

Biovail orally disintegrating citalopram





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