By Ronit Goodman – Dec 26, 2010
Teva Pharmaceutical Industries Ltd. climbed the most in more than two weeks on speculation failure by the company to win U.S. approval for a new formulation of its multiple sclerosis drug Copaxone means it will be more difficult for competitors to enter the market.
Teva received a complete response letter from the Food and Drug Administration saying the company’s application for the new formulation of Copaxone with a higher concentration of medicine can’t be approved as submitted and may require a new study to prove it works, the company said Dec. 23.
“Given that the FDA is requiring clinical trial efficacy data from the originator because of a concentration change, the likelihood of the FDA requiring clinical trials for generics is even higher,” John Boris, an analyst at Citigroup Inc. in New York, wrote in a Dec. 23 report.
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