Printer Friendly
The Free Library
19,607,059 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Biovail Receives FDA Approval for Novel Once Daily Diltiazem Formulation - New Drug Application Optioned to Forest Laboratories.


Business Editors, Health/Medical Writers

TORONTO--(BW HealthWire)--March 6, 2000

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
) (TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
:BVF) today announced that it has received approval from the Food and Drug Administration for its New Drug Application of a novel once daily controlled release formulation of Diltiazem Hcl.

Biovail has granted to Forest Laboratories, Inc., Biovail's licensee of Tiazac, an option to acquire the exclusive right to market the product in the United States. Under the terms of the option agreement, Forest has the right to negotiate a license and supply agreement with Biovail containing terms for the supply by Biovail of the product similar to those on which Biovail supplies its Tiazac product to Forest.

Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies.

"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 their release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting 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.
 and TPD TPD Tons Per Day
TPD Therapeutic Products Directorate
TPD Total and Permanent Disablement (insurance)
TPD Temperature Programmed Desorption
TPD Temporary Partial Disability (insurance) 
 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, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, 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
Date:Mar 6, 2000
Words:241
Previous Article:Schwartz Communications Promotes Laura Kempke to Vice President.
Next Article:Boundless Manufacturing Services Closes Two Deals.
Topics:



Related Articles
Biovail's Diltiazem once-daily clears FDA review; licensee Hoechst-Roussel places additional CDN $7.5 million manufacturing order.
Biovail announces Forest Laboratories to make cash tender offer for 1.8 million Biovail shares at U.S. $42 per share; Licenses rights to Tiazac, its...
Biovail Corporation International reports 1995 fourth quarter and year end financial results.
Biovail Corporation's Tiazac approved in United Kingdom; additional approvals expected IN SECOND HALF 1996 -Initial European Shipments in Fourth...
Biovail Launches Tiazac In Canada; Crystaal Corporation, Biovail's Newly Created Wholly-Owned Subsidiary, to Market.
FDA Tentatively Approves Andrx ANDA For Tiazac.
Biovail Confirms Tiazac Patent Listing in FDA Orange Book.
FDA APPROVES BIOVAIL'S GENERIC PROCARDIA XL 30MG DOSAGE.
Andrx Announces Court Ruling in Its Favor; Authorizes Earlier FDA Approval of Andrx's Generic Tiazac.
Biovail Receives Approvable Letter for Cardizem XL.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles