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


HYDERABAD, India -- Dr. Reddy's Laboratories (NYSE: RDY RDY - Ready) announced today that the U. S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Citalopram
1. an antidepressant compound used in the treatment of major depressive disorder, administered orally as the hydrobromide hydrobromide /hy·dro·bro·mide/ (-bro´mid) an addition salt of hydrobromic acid..
2. a selective serotonin reuptake inhibitor used as the hydrobromide salt as an antidepressant.
 hydrobromide tablets 10 mg, 20 mg and 40 mg. The Company will commence the commercial marketing of this product immediately.

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 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. 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 ci·tal·o·pram hy·dro·bro·mide (s-tl-pr is the AB-rated generic equivalent of Forest Laboratories' Celexa Ce·lex·a (s-lks(R). Celexa(R) is indicated for the treatment of depression. As per IMS 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 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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