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Dr. Reddy's announces USFDA approval for Citalopram Hydrobromide tablets.


HYDERABAD, India -- Dr. Reddy's Laboratories Dr. Reddy’s Laboratories Ltd. (Reddy's), founded in 1984 by Dr. K. Anji Reddy, has become India’s third biggest pharmaceutical company. Reddy had worked in the publicly-owned Indian Drugs and Pharmaceuticals Ltd.  (NYSE NYSE

See: New York Stock Exchange
: RDY) announced today that the U. S. Food and Drug Administration has granted final approval for 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) for Citalopram hydrobromide tablets 10 mg, 20 mg and 40 mg. The Company will commence the commercial marketing of this product immediately.

GV Prasad, Chief Executive Officer of Dr. Reddy's said, "We are pleased to be among the first to get the USFDA USFDA United States Food & Drug Administration  approval for Citalopram citalopram /ci·tal·o·pram/ (si-tal´o-pram)
1. an antidepressant compound used in the treatment of major depressive disorder, administered orally as the hydrobromide.

2.
. We will be launching this product immediately through our own sales and marketing network and its represents a significant addition to our existing portfolio of generic products for the US market".

Citalopram hydrobromide is the AB-rated generic equivalent of Forest Laboratories' Celexa(R). Celexa(R) is indicated for the treatment of depression. As per IMS (1) See IP Multimedia Subsystem.

(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS.
 June 2004, the product had annual US brand sales of approximately $1.4 billion.

About Dr. Reddy's

Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The Company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.

This press release includes forward-looking statements, as defined in the U.S. 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. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.
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.

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Publication:Business Wire
Date:Oct 28, 2004
Words:333
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