Dr. Reddy's Receives USFDA Approval for Fexofenadine Hydrochloride.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 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 fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg. The Company will commence the commercial marketing of this product immediately. In September 2002, Dr. Reddy's filed the ANDA for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg with a Para IV certification on all orange book patents. Dr. Reddy's was granted summary judgment with respect to 3 patents. Five patents remain in the litigation. The litigation is pending at the United States District Court for the District of New Jersey The United States District Court for the District of New Jersey is the Federal district court whose jurisdiction is the state of New Jersey. It was established in 1789. New Jersey is the largest state by population to only have one District Court. The Honorable Garrett E. . No date is currently set for trial. The 30-month period identified in section 505(j)(5)(B)(iii) of the Federal Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. has expired. The 180-day generic drug exclusivity awarded to Barr Laboratories has also expired. Fexofenadine hydrochloride is the AB-rated generic equivalent of Sanofi-Aventis' Allegra(R). Allegra(R) is indicated for the relief of symptoms associated with 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. and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. 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. December 2005, 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 diabetes, cardiovascular, anti-infectives, inflammation and cancer. Disclaimer 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. |
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