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

Andrx Announces FDA Approvable Letter for Cardura XL.


FORT LAUDERDALE, Fla. -- Andrx Corporation ("Andrx" or "Company") (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced 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 issued an approvable letter for Pfizer Inc.'s ("Pfizer") New Drug Application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ") for Cardura(R) XL, a sustained-release formulation of doxazosin mesylate dox·a·zo·sin mesylate
n.
An alpha-blocker drug used to treat hypertension and benign prostatic hyperplasia.


doxazosin mesylate
(doksā´zōsin mes´ilāt´),
n brand name:
, used to treat benign prostatic hyperplasia benign prostatic hyperplasia
n. Abbr. BPH
A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine.
 (BPH BPH
abbr.
benign prostatic hyperplasia


BPH
Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men.
). As previously announced, Andrx will receive exclusive distribution rights to Cardura XL in the United States upon the approval of the product with certain minimum claims. The FDA's approvable letter sets out the conditions that must be met before final marketing approval is obtained. Pfizer has responsibility for the NDA and has informed us that it intends to respond promptly to the conditions of the approvable letter.

About Andrx Corporation

Andrx Corporation is a pharmaceutical company that: develops and commercializes generic versions of controlled-release brand name pharmaceuticals, using the Company's proprietary controlled-release drug delivery technologies, and generic versions of niche and immediate-release pharmaceutical products, including oral contraceptives Oral Contraceptives Definition

Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills.
; distributes pharmaceuticals, primarily generics, manufactured by others as well as manufactured by the Company, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices; and commercializes brand pharmaceuticals, in some instances using the Company's proprietary controlled-release drug delivery technologies.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of 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. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," " plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the Company's dependence on a relatively small number of products; licensing revenues; the timing and outcome of patent, antitrust and other litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
; the timing and commercial success of future generic product launches; whether the Company will be awarded any market exclusivity period and, if so, the precise dates thereof; government regulation generally; competition; manufacturing capacities, output and quality processes; the Company's ability to develop and successfully commercialize new products; the loss of revenues from existing products; development and marketing expenses that may not result in commercially successful products; the Company's inability to obtain, or the high cost of obtaining, licenses for third party technologies; commercial obstacles to the successful introduction of brand products generally, including Cardura XL; the success of the Company's joint ventures; the impact of returns, allowances and chargebacks; product liability claims; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission. Andrx disclaims any responsibility to update the statements contained herein.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, 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:Jun 21, 2004
Words:525
Previous Article:Tax Breaks Offer Incentive for Small, Medium-Size Businesses to Invest in Technology, States ITSPA.
Next Article:Atempo's Time Navigator Certified by Network Appliance for Data ONTAP.
Topics:



Related Articles
Biovail Receives Approvable Letter for Cardizem XL.
Andrx Receives FDA Approvable Letter for Fortamet.
Andrx Acquires U.S. Distribution Rights to Pfizer's Cardura XL; Will Expand Andrx's Brand Product Portfolio.
Andrx Reorganizes its Branded Operations.
Andrx Announces Pending ANDA Filings For Concerta; Approval Affected By Citizen Petition.
Andrx Launches Its Generic Version of Vicoprofen.
Andrx Receives FDA Approval of Fortamet; Also Plans to Market Altocor Under A New Name.
Andrx Reports First Quarter 2004 Results.
Andrx To Focus on Generic and Distribution Businesses; To Exit Brand Business; Terminates Agreement To Distribute Cardura XL.
NEUROMED LICENSES PHASE 3 CHRONIC PAIN PRODUCT FROM ALZA.

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