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Once-daily beta-blocker in the FDA pipeline

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IRVINE, Calif. — U.S. regulators will review a new drug application for a once-daily formulation of timolol, a leading beta-blocker for lowering intraocular pressure.

The drug, to be marketed as Istalol pending regulatory approval, has been shown in studies to be comparable in efficacy and safety to twice-daily formulations of timolol maleate, according to a news release from the drug’s U.S. marketer, Ista Pharmaceuticals. Because this formulation of timolol is once-daily, Ista believes the drug will not be vulnerable to generic competition if the Food and Drug Administration approves its use.

The new drug application was initially filed in September 2002. The drug’s developer, Senju Pharmaceutical Co., retains all rights to the drug outside the U.S.