Printer Friendly
The Free Library
4,489,648 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

IVAX Receives Final Approval for Buspirone.


Business Editors/Health & Medical Writers

MIAMI--(BUSINESS WIRE)--March 1, 2002

IVAX Corporation (AMEX:IVX) (LSE:IVX.L) reported that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) and has started marketing its buspirone buspirone /bu·spi·rone/ (bu-spi´ron) an antianxiety agent used as the hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid.

hy·dro·chlo·ride (hdr
 salt in the treatment of anxiety disorders and the short-term relief of anxiety symptoms.
 hydrochloride tablets in 5 mg, 10 mg and 15 mg strengths through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Buspirone hydrochloride bu·spi·rone hydrochloride (by-sprn is the generic equivalent of Bristol-Myers Squibb Company's Buspar Bu·spar (byspär)
A trademark for the drug buspirone hydrochloride.
(R) and is used in the management of anxiety disorders. U.S. sales of branded and generic buspirone hydrochloride were approximately $630 million during the past year.

IVAX currently has 36 ANDAs and two tentative approvals pending at the FDA. The company is continuing its aggressive filing schedule for new ANDA submissions.

IVAX Corporation, headquartered in Miami, Florida, is engaged in the research, development, manufacturing, and marketing of branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and international markets.

Copies of this and other news releases may be obtained free of charge from IVAX' web site at http://www.ivax.com. Shareholders and prospective investors can register to automatically receive the company's press releases via email at http://www.ivax.com/ComNewsv2.htm.

The "FDA" refers to the United States Food and Drug Administration.

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' pending ANDAs and tentative approvals and filing schedule for ANDA submissions, involve risks and uncertainties which may affect the company's business and prospects, including the risks related to changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; that IVAX may not receive approval of its pending ANDAs or final approval of its tentatively approved ANDAs, or that if approved, the products will not be successfully commercialized; that IVAX may not file any additional ANDAs; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's 2000 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Buspar(R) is a registered trademark of Bristol-Myers Squibb Company.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, 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:1USA
Date:Mar 1, 2002
Words:383
Previous Article:Medtronic Announces FDA Approval of Marquis DR Implantable Cardioverter-Defibrillator.
Next Article:Medi-Hut Co., Inc. Issues Statement.
Topics:



Related Articles
IVAX Announces Generic Drug Approval for Cimetidine and Two Tentative Generic Approvals.
IVAX GETS APPROVAL TO MARKET PAXENE IN CANADA.(Brief Article)(Statistical Data Included)
Developer of Cancer Drug Sues the FDA.(American BioScience Inc.)(Brief Article)
Mylan Files Suits on Buspirone.
Mylan Receives Approval for Buspirone 15 mg.
IVAX' Metformin Approvable by FDA.
IVAX Receives Final Approval for Metformin.
IVAX to Market Tramadol.
IVAX Receives Final Approval for Fluoxetine.
IVAX' Gabapentin Approvable by FDA.

Terms of use | Copyright © 2008 Farlex, Inc. | Feedback | For webmasters | Submit articles