Printer Friendly

SYNTEX RECEIVES FDA CLEARANCE FOR KETOROLAC OPHTHALMIC; ALLERGAN TO MARKET FIRST NSAID FOR SEASONAL ALLERGIC CONJUNCTIVITIS

 SYNTEX RECEIVES FDA CLEARANCE FOR KETOROLAC OPHTHALMIC; ALLERGAN TO MARKET FIRST NSAID FOR SEASONAL ALLERGIC CONJUNCTIVITIS
 PALO ALTO, Calif., Nov. 11 /PR Newswire/ -- Syntex Corp. (NYSE: SYN) announced today that the United States Food and Drug Administration (FDA) has cleared for marketing an ophthalmic formulation of ketorolac tromethamine in the United States for the relief of ocular itching due to seasonal allergic conjunctivitis, which is characterized by itchy, watery eyes.
 Syntex has granted Allergan Inc., of Irvine, Calif., worldwide marketing rights, with the exception of Japan. Under terms of the manufacturing and distribution agreement with Allergan, Syntex will manufacture the active ingredient in ketorolac ophthalmic, and Allergan will manufacture and market the ophthalmic formulation. Additional terms of the agreement were not disclosed.
 Ketorolac ophthalmic, the first topical nonsteroidal anti-inflammatory agent to receive an indication for seasonal allergic conjunctivitis in the United States, will be sold under the trade name ACULAR(R) sterile ophthalmic solution, 0.5 percent. Approximately 5 percent of the U.S. population suffers from the ocular complications of seasonal allergic conjunctivitis.
 ACULAR is expected to be available for physicians to prescribe for their patients by early spring.
 Controlled clinical studies have shown ACULAR to be significantly more effective than placebo in reducing itching associated with seasonal allergic conjunctivitis. Results from clinical studies indicated that ACULAR ophthalmic solution has no significant effect upon intraocular pressure. The most frequent side effects reported were transient stinging and burning. ACULAR can be safely administered in conjunction with other ophthalmic medications, including antibiotics and beta-blockers.
 ACULAR will be available in 10 ml dropper bottles filled with 5 ml of solution.
 Syntex currently markets an intramuscular (IM) and an oral (tablet) formulation of ketorolac tromethamine in the United States. The IM formulation is indicated for the short-term management (up to 5 days) of pain, while the oral formulation is prescribed for limited-duration use in the management of pain. Syntex also markets the oral and intramuscular formulations in many countries around the world, including the United Kingdom, Germany, Canada and Italy, where it is handled for Syntex by two distributors.
 Allergan currently markets ACULAR ophthalmic solution in Canada and the Netherlands. Ketorolac ophthalmic solution is also approved for patient use in Belgium, France, Germany and New Zealand.
 Syntex is a multinational healthcare company that discovers, develops, manufactures and markets prescription medicines that treat serious human diseases. Syntex also develops, manufactures and markets animal pharmaceutical products and medical diagnostic systems.
 Allergan Inc., a global provider of specialty therapeutic products, has a leadership position in eye care.
 - 0 - 11/11/92
 /CONTACT: Jan Potts of Syntex, 415-852-1321, or Shel Holtz of Allergan, 714-752-4387/
 (SYN) CO: Syntex Corporation; Allergan Inc. ST: California IN: MTC SU: PDT


TM -- SJ001 -- 9928 11/11/92 17:50 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Nov 11, 1992
Words:458
Previous Article:ACTON ANNOUNCES CLOSING OF HICKORY WHITE COMPANY PLANT
Next Article:SEISMED INSTRUMENTS COMPLETES OFFERING AND PUBLICATION OF CLINICAL RESULTS
Topics:


Related Articles
Pharmos Submits NDA for New Ophthalmic Product
Bausch & Lomb Announces NDA Submission for New Ophthalmic Drug Product
Akorn Reports Piroxicam Enters Multicenter Phase III Clinical Trials

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters