Allergan Comments On Restasis Approvable Letter.IRVINE, Calif.--(BW HealthWire)--Aug. 24, 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 the Division of Anti-Inflammatory, Analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs and Ophthalmic Drug Products of 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. ) has issued an "approvable letter" to the Company which relates to the new drug application for Restasis(TM) (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%.) This letter outlines several points that must be fully addressed by Allergan before the application may be approved by the FDA. Allergan is continuing its dialogue with the FDA to determine how best to respond to the points raised in this letter.Any of the above statements that refer to, or could be read to refer to, events that may occur in the future are forward-looking and reflect information currently available to the Company. In particular, although the FDA has sent Allergan an approvable letter regarding Restasis(TM), a number of significant issues must be addressed before Restasis(TM) could be approved. As is typical of a scientific project of this nature, Allergan can provide no assurances that the points raised in the approvable letter can be adequately addressed by the Company to the FDA's satisfaction; no assurance can be made that the FDA will ultimately approve Restasis(TM); no assurance can be made as to when, if ever, Restasis(TM) will be approved; and, if approved, no assurance can be made that the approved indications will be identical to those sought by the Company. The Company disclaims any intent or obligation to update these forward-looking statements. Allergan, Inc. headquartered in Irvine, California Irvine is an incorporated city in Orange County, California, United States. It is a planned city, mainly developed by the Irvine Company since the 1960s. Formally incorporated on December 28 1971, the 69.7 square mile (180.5 km²) city has a population of 202,079 (as of 2007). , is a technology-driven, global health care 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. |
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