Printer Friendly
The Free Library
14,528,975 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Biovail Exclusivity for Tramadol ER Confirmed by FDA.


TORONTO -- Biovail Corporation (NYSE NYSE

See: New York Stock Exchange
:BVF BVF Biovail Corporation (stock symbol)
BVF Berufsverband der Frauenärzte eV (Muenchen, Germany)
BVF Bearing Versus Frequency
)(TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:BVF) announced today that the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has confirmed - and has posted on its Orange Book Web site - that Biovail's once-daily extended-release formulation of tramadol (Tramadol ER) has received three years of exclusivity, covering all dosages.

"Being the first-to-market with a once-daily formulation of tramadol is a significant competitive advantage," said Biovail Chief Executive Officer Dr. Douglas Squires. "The additional benefit of three years of market exclusivity only enhances the value of Tramadol ER."

About Biovail Corporation

Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at www.biovail.com.

For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

"Safe Harbor" Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995

To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration and Canadian Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States.  approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, tax rate assumptions, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance. . Biovail undertakes no obligation to update or revise any forward-looking statement.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1CANA
Date:Oct 21, 2005
Words:379
Previous Article:Magna Entertainment and Forest City Announce Joint Venture Partnership Agreement for The Village at Gulfstream Park.
Next Article:St. Mary Board Declares Semi-Annual Cash Dividend.
Topics:



Related Articles
FDA APPROVES BIOVAIL'S GENERIC PROCARDIA XL 30MG DOSAGE.
CORRECTING and REPLACING Biovail NDA For Ralivia ER -- Tramadol Extended Release Tablets -- Accepted for Review.
Biovail Submits NDA for Ralivia FlashDose.
Biovail's Ralivia ER Receives Approvable Letter From FDA.
Biovail Updates Status of NDA for Tramadol ER.
Biovail's Tramadol ER Receives FDA Approval.
LABOPHARM/PURDUE PHARMA SIGN TRAMADOL LICENSING PACT.
Biovail Enters Into Commercial Alliance for Tramadol Products.
Biovail, Ortho-McNeil Partnership Receives Hart-Scott-Rodino Regulatory Clearance.
LABOPHARM GRANTS TRAMDOL MARKETING RIGHTS TO PURDUE PHARMA.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles