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Dr Reddy's Announces USFDA Approval for Tizanidine HCL Tabs
Business Wire, July 3, 2002
Business Editors and Medical/Health Writers
Dr Reddy's Laboratories Ltd. (NYSE: RDY) announced today that the U. S. Food and Drug Administration has issued final approval for the Company's ANDA for Tizanidine Hydrochloride tablets 2 mg and 4 mg.
Dr Reddy's also announced that the product will be shipped immediately and marketed though it's alliance partner, Par Pharmaceuticals.
Tizanidine hydrochloride is the AB-rated generic equivalent of Elan Corporation's Zanaflex(R). Zanaflex(R) is indicated for the management of increased muscle tone associated with spasticity, a condition affecting the central nervous system ("CNS") causing muscle stiffness and rigidity. As per IMS 2001, the product had annual US brand sales of approximately $160 million.
About Dr. Reddy's
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven basic research capabilities. The company develops, manufactures and markets a wide range of pharmaceutical products in India and overseas. Dr. Reddy's produces finished dosage forms, active pharmaceutical ingredients, diagnostic kits, critical care and biotechnology products. The basic research program of Dr. Reddy's focuses on cancer, diabetes, bacterial infections and pain management.
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.
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