Allergan Receives U.S. Food and Drug Administration Approval for TRIVARIS(TM) (triamcinolone acetonide injectable suspension) 80 mg/mL.-- Optimized Triamcinolone triamcinolone /tri·am·cin·o·lone/ (tri?am-sin´o-lon) a synthetic glucocorticoid used in replacement therapy for adrenocortical insufficiency and as an antiinflammatory and immunosuppressant in a wide variety of disorders. Formulation Developed for Ocular Use -- IRVINE, Calif. -- 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) ) today announced that 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 approved TRIVARIS([TM])(triamcinolone acetonide triamcinolone acetonide (topical) (as´  tō´nīd),n brand names: injectable suspension) 80 mg/mL, a synthetic glucocorticoid glucocorticoid /glu·co·cor·ti·coid/ (-kor´ti-koid) 1. any of the group of corticosteroids predominantly involved in carbohydrate metabolism, and also in fat and protein metabolism and many other activities (e.g. corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and with anti-inflammatory action. Delivered via intravitreal injection, the ophthalmic indications for TRIVARIS([TM]) include sympathetic ophthalmia sympathetic ophthalmia n. A swelling of the uvea in an uninjured eye caused by a wound of the uvea of the other eye. It may eventually lead to bilateral blindness. , temporal arteritis, uveitis uveitis Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness. , and ocular inflammatory conditions unresponsive to topical corticosteroids. These are inflammatory conditions that can result in vision loss. "Retinal diseases are currently the leading cause of blindness in developed countries and represent a significant unmet need in eye care," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "TRIVARIS([TM]) marks the first approval for Allergan resulting from our strategic focus on the development of therapies for back-of-the-eye diseases, and we remain committed to bringing forth innovative new treatments for patients suffering from retinal diseases." Important Safety Information Prolonged use of corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of possible corneal corneal pertaining to the cornea. See also keratitis, keratopathy. corneal anomaly includes microcornea, coloboma, megalocornea, dermoid, congenital opacity. corneal black body see corneal sequestrum (below). perforation per·fo·ra·tion n. 1. The act of perforating or the state of being perforated. 2. An abnormal opening in a hollow organ or viscus, as one made by rupture or injury. Perforation A hole. . Corticosteroids should not be used in active ocular herpes simplex. Full prescribing information is available at www.allergan.com. About Allergan, Inc. Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries. Forward-Looking Statements This press release contains "forward-looking statements", including statements by Dr. Whitcup, certain statements regarding regulatory approvals and indications, certain claims regarding the treatment of retinal diseases and other statements regarding the safety and efficacy of TRIVARIS([TM]). These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product formulation; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2007 Form 10-K and Allergan's Form 10-Q for the quarter ended March 31, 2008. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636. ([TM])Marks owned by Allergan, Inc. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion