Alcon Amends NDA for Patanase(R) Nasal Spray.HUENENBERG, Switzerland -- Alcon, Inc. (NYSE NYSE See: New York Stock Exchange : ACL See access control list. 1. ACL - Access Control List. 2. ACL - Association for Computational Linguistics. 3. ACL - A Coroutine Language. A Pascal-based implementation of coroutines. ["Coroutines", C.D. ) announced today that it has submitted to the U.S. Food and Drug Administration (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. ) an amendment to its pending new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for PATANASE([R]) (olopatadine hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. ) nasal spray. The pending NDA is for the treatment 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. in adults and adolescents twelve years of age and older. The amendment includes interim six-month data from an agreed-upon study previously requested by the FDA to support a modification of the formulation of PATANASE([R]) nasal spray. "I am happy to see that PATANASE([R]) is moving forward to FDA review because I believe it will provide an attractive treatment option for patients with seasonal allergic rhinitis," said Dr. Rohit Katial, a principal investigator for PATANASE([R]) and Associate Professor of Medicine at National Jewish Medical and Research Center National Jewish Medical and Research Center is a research institute located in Denver, Colorado specializing in respiratory, immune and allergic research and treatment. It was founded in 1899 to treat tuberculosis, and is today considered one of the world's best medical research , Denver, Colorado. "Data collected through multiple studies that make up the current NDA demonstrate that PATANASE([R]) provides rapid relief from bothersome nasal allergy symptoms." The active ingredient in PATANASE([R]) nasal spray, olopatadine hydrochloride, is the same active ingredient used in Alcon's market-leading family of products for ocular allergies, which includes PATADAY(TM) ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. and PATANOL([R]) ophthalmic solution. Previous clinical studies of the nasal formulation of olopatadine hydrochloride demonstrated the efficacy of PATANASE([R]) nasal spray in the treatment of the symptoms of seasonal allergies. "PATANASE([R]) represents an opportunity for Alcon to enhance its portfolio of topical anti-allergy treatments and support the growth of our pharmaceutical business," said Kevin Buehler, Alcon's senior vice president, global markets and chief marketing officer. "We will provide the FDA with additional data during their review of our amended NDA, including the final results of the requested study." About Allergic Rhinitis Allergic rhinitis, the medical term for nasal allergies, refers to an allergic complex of symptoms caused by sensitivity to pollens, mold, dust or animal dander. Symptoms may include congestion The condition of a network when there is not enough bandwidth to support the current traffic load. congestion - When the offered load of a data communication path exceeds the capacity. , sneezing To verbally tell somebody about a new and interesting Web site. See viral marketing. , itchy nose, excess mucus, watery eyes, itchy eyes, sinus headaches and a scratchy palate and throat. Allergies can affect people seasonally or throughout the year. According to the American Academy of Allergy, Asthma and Immunology, allergies affect as many as 40 to 50 million people in the United States. Incidence has risen significantly in the last two decades. At least 35.9 million Americans have seasonal allergic rhinitis, resulting in approximately 16.7 million office visits to health care providers each year. Allergies are not only bothersome, but have been linked to a variety of common and serious chronic respiratory illnesses, such as sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. and asthma. About Alcon (NYSE: ACL) Alcon, Inc. is the world's leading eye care company, with sales of approximately $4.9 billion in 2006. Alcon, which has been dedicated to the ophthalmic industry for 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon's majority shareholder is Nestle, S.A., the world's largest food company. Caution Concerning Forward-Looking Statements. This press release may contain forward-looking statements within the meaning of the United States 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. Any forward-looking statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, the following: we may never receive FDA approval of our NDA for PATANASE([R]) nasal spray; approval of the NDA may take longer than we expect; treatments developed by other companies may be or may be perceived to be more effective than PATANASE([R]) nasal spray; challenges inherent in new product marketing may adversely affect our ability to market the drug; and governmental regulation and legislation could have an impact on our business beyond our control. You should read this press release with the understanding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities laws and the rules and regulations promulgated prom·ul·gate tr.v. prom·ul·gat·ed, prom·ul·gat·ing, prom·ul·gates 1. To make known (a decree, for example) by public declaration; announce officially. See Synonyms at announce. 2. by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise. |
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