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

Biovail tramadol ODT approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biovail will select a trade name for its orally disintegrating tramadol (formerly Ralivia FlashDose) once it finds a marketing partner for the opioid analgesic, cleared May 5 for moderate to moderately severe pain in adults. Late-stage discussions with potential partners are underway, the firm said. Biovail also has an extended-release tramadol formulation (formerly Ralivia ER) pending, which has been "approvable" since October 2004. The firm expects to submit additional data in late 2005/early 2006 (1Pharmaceutical Approvals Monthly April 2005, In Brief)...

You may also be interested in...



Biovail tramadol ER needs more data

Biovail expects to submit data from a new clinical trial of its orally disintegrating extended-release tramadol product in late 2005/early 2006, the firm said March 30. The announcement follows initial feedback from FDA regarding Biovail's March 2005 complete response to an October 2004 "approvable" letter for the opioid analgesic. "Upon preliminary review, [FDA said] it is of the opinion that additional clinical trial data will be required," the company said. Biovail maintains that its 505(b)(2) NDA is sufficient and plans to meet with FDA to discuss its options. The setback could allow Labopharm to file its extended-release tramadol ahead of Biovail; the Canadian firm previously projected a second-half 2005 filing (1Pharmaceutical Approvals Monthly October 2004, p. 7)...

Warning Letter Roundup & Recap – 22 September 2020

No device-related warning letters were released by the US FDA the week of 22 September.

Neuraxpharm Snapped Up By Private Equity In Europe’s Largest Deal

Created in 2016 by consolidating five European companies, CNS specialist Neuraxpharm is changing hands, with funds advised by global investor Permira paying an undisclosed sum to take control of a business boasting annual revenues of around €460m ($541m) and more than 115 CNS molecules at its disposal.

Topics

UsernamePublicRestriction

Register

LL016789

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