Printer Friendly
The Free Library
14,588,739 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Andrx Comments on FDA Approval of its Generic OTC Claritin-D 12.


Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 29, 2004

Andrx Corporation (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 approved the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  (ANDA ANDA
abbr.
abbreviated new drug application
) for Loratadine and Pseudoephedrine Sulfate Extended-release Tablets 5 mg/120 mg (12-Hour Formulation), which are bioequivalent bi·o·e·quiv·a·lent
n.
A value indicating the rate at which a substance enters the bloodstream and becomes available to the body.
 to Schering Corporation's Claritin-D(R) 12 Hour Extended-release Tablets (Claritin-D12). Labeled for the relief of symptoms of seasonal allergic rhinitis seasonal allergic rhinitis,
n See hay fever.

seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis.
 (hay fever), this product will be marketed as an over-the-counter (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
) product by Perrigo Company, the nation's largest provider of store brand OTC pharmaceuticals. Perrigo is presently marketing Andrx's bioequivalent OTC versions of Claritin-D(R) 24 and recently began shipment of the Company's OTC Claritin RediTabs(R) product into the trade. The Company does not presently have a launch date for its OTC version of Claritin-D12 as it prioritizing its manufacturing efforts among its various products.

Larry Rosenthal, President of Andrx Pharmaceuticals, said: "We are very pleased that our OTC Claritin RediTabs will soon be on store shelves joining our OTC Claritin D-24 product and that our OTC Claritin-D12 has now been approved."

About Andrx Corporation:

Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals, using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx also has distribution operations, which purchase primarily generic pharmaceuticals manufactured by third parties and sell them primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and, to a lesser extent, physicians' offices.

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 of FDA approvals for the Company's ANDAs; the successful scale-up, timing and commercial success of future product launches, including OTC Claritin D-12; the timing and outcome of 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.
; government regulation; competition; and manufacturing results. 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:Jan 29, 2004
Words:504
Previous Article:Schaeffer's Street Chatter Highlights the Following Stocks: Foundry Networks, JetBlue Airways, and Sears, Roebuck and Co.
Next Article:A.M. Best Affirms Rating of Max Re Ltd.
Topics:



Related Articles
Andrx Granted FDA Tentative Approval for Generic Claritin-D24.
Andrx and Perrigo Announce Agreement To Market Loratadine Products.
Andrx Receives Approvals for Generic Claritin-D 24 and Nolvadex.
Andrx Corporation Reports 2002 Fourth Quarter and Full Year Results.
State acts to stop HMOs from restricting coverage of drugs. (Up Front).
Andrx Corporation Reports 2003 First Quarter Results.
Andrx Launch Underway for Generic Claritin-D 24.
Andrx Receives FDA Approval for Loratadine Orally Disintegrating Tablets.
Andrx Reports 2003 Fourth Quarter and Full Year Results.
Rx for costs: health insurers are finding generic, over-the-counter and mail-order drugs are the right prescription to help reduce the nation's...

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