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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.
Forward-Looking Statements
This press release contains "forward-looking statements," such as statements regarding ACULAR LS(TM) ophthalmic solution, potential growth rates, adverse effects and availability of this product. 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 ...
Source: HighBeam Research, Allergan Announces FDA Approval of ACULAR LS Ophthalmic Solution; The...