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Allergan Announces FDA Approval of ACULAR LS Ophthalmic Solution; The New Formulation of the #1 Prescribed Ophthalmic NSAID in the United States.
Business Editors/Health/Medical Writers
IRVINE, Calif.--(BUSINESS WIRE)--June 2, 2003
Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved ACULAR LS(TM) (ketorolac tromethamine ophthalmic solution) 0.4% for the reduction of ocular pain and burning/stinging following corneal refractive surgery.
ACULAR LS(TM) is a new, optimized formulation of ketorolac tromethamine and joins this family of products used for a range of other conditions including post-surgical inflammation, pain, photophobia and ocular itch associated with seasonal allergies. ACULAR LS(TM) will be available in a convenient multi-dose bottle and is currently expected to launch in the third quarter of this year.
In clinical studies, ACULAR LS(TM) significantly reduced pain, burning and stinging following corneal refractive surgery. The most frequently reported adverse reactions for ACULAR LS(TM) ophthalmic solution, occurring in approximately 1 to 5% of the overall study population, were ocular redness, swelling and pain, corneal infiltrates and headache.
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