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Takeda's Hopes For Replacement Diabetes Drug May Hit U.S. FDA Wall

This article was originally published in PharmAsia News

Executive Summary

Takeda Pharmaceutical's SYR-322 (alogliptin) diabetes drug, which it was relying on to take the place of one of its best-sellers, may be headed for a four-year delay in getting U.S. FDA approval. The drug maker faces the possibility of having to conduct more clinical trials to determine the drug's contribution to the risk of heart attacks and strokes. An FDA decision on whether to require the tests is considered imminent. Takeda was counting on the drug to be on the market in time to cushion losses when its Actos (pioglitazone) diabetes drug loses U.S. patent protection. (Click here for more



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