Reuters: Regulatory News: Teva CEO sees Q1 2014 FDA action on 3-times-a-week Copaxone

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Teva CEO sees Q1 2014 FDA action on 3-times-a-week Copaxone May 2nd 2013, 12:35 JERUSALEM | Thu May 2, 2013 8:35am EDT JERUSALEM May 2 (Reuters) - Teva Pharmaceutical Industries , the world's largest generic drugmaker, expects U.S. regulators to act on its more convenient three-times-a-week dosing regimen of multiple sclerosis drug Copaxone in early 2014. Teva submitted its application for the drug, which will dose 40 mg three-times-a-week instead of the current daily dose of 20 mg, at the end of March. "We anticipate FDA action in the first quarter next year," Chief Executive Jeremy Levin told a conference call of analysts after Teva issued first-quarter results on Thursday. Among Teva's key challenges is the looming 2015 patent expiration of its most important branded product, the multiple sclerosis drug Copaxone, which accounts for about 20 percent of sales and some 50 percent of profit.

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