February 18, 2004
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FTC closes generic ketorolac case

IRVINE, Calif. — Late last week, the Federal Trade Commission officially closed its investigation regarding alleged attempts to keep generic ketorolac tromethamine off the market, Allergan announced in a press release.

The FTC’s decision to close the investigation follows a California District Court ruling at the end of last year in favor of Allergan and Syntex, concluding that their patent on Acular (ketorolac tromethamine ophthalmic solution 0.5%) is valid and enforceable and that it was being infringed by a comparable generic being marketed by Apotex and Novex Pharma.

Acular is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis and the treatment of postoperative inflammation in patients who have undergone cataract surgery.