Allergan, Inc. Company Statement Regarding Outcome of July 21 FDA Committee Hearing.IRVINE, Calif.--(BW HealthWire)--July 21, 1999-- Allergan, Inc. (NYSE NYSE See: New York Stock Exchange : AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) confirms that today the Dermatologic and Ophthalmic Drugs Advisory Committee 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. ) voted against recommending the approval of the company's new therapy for the treatment of moderate-to-severe chronic dry eye disease, or keratoconjunctivitis sicca keratoconjunctivitis sic·ca n. See dry eye. keratoconjunctivitis sicca (ker´ (KCS KCS keratoconjunctivitis sicca. ). The FDA can accept or reject the Committee's decision. Allergan has great confidence in its novel therapeutic treatment and is reviewing the Committee's recommendations. "We will work very closely with the FDA to address the issues raised during today's advisory committee meeting," said Les Kaplan, Corporate Vice President, Research and Development, Allergan. "Chronic dry eye disease affects up to three million Americans, and we believe that new options are needed for the treatment of this painful and potentially debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction condition." More About Allergan Allergan, Inc., headquartered in Irvine, California, is a technology-driven, global healthcare company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care pharmaceutical, ophthalmic surgical device, over-the-counter contact lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience. care, movement disorder, and dermatological markets that deliver value to our customers, satisfy unmet medical needs and improve patients' lives. Forward-looking Statement Any of the above statements that refer to Allergan's estimated or anticipated future results are forward-looking and reflect the Company's current analysis of existing trends and information. Actual results may differ from current expectations based on a number of factors affecting Allergan's businesses, including the timing and uncertainty of the results of both research and regulatory processes, and including the research, development, regulatory approval, introduction and consumer acceptance of new products. In particular, there can be no assurance that the U.S. Food and Drug Administration will ultimately approve cyclosporine ophthalmic emulsion cyclosporine ophthalmic emulsion Sandimmun (UK), Restasis Pharmacologic class: Polypeptide antibiotic Therapeutic class: Immunosuppressant Pregnancy risk category C FDA Boxed Warning, 0.05%, or approve cyclosporine ophthalmic emulsion, 0.05% for the indication currently sought, or approve it on an expedited basis. These forward-looking statements represent the Company's judgement only as of the date of this press release. Actual results could differ materially from those projected in this release. Therefore, the reader is cautioned not to rely on these forward-looking statements. The Company disclaims, however, any intent or obligation to update these forward-looking statements. |
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