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Takeda Says U.S. FDA To Delay Approval Of Replacement Diabetes Drug

This article was originally published in PharmAsia News

Executive Summary

Takeda Pharmaceutical said U.S. FDA has delayed review of alogliptin until the Japanese drug maker can supply more data about the diabetes drug. The delay was seen as a blow to Takeda, which faces a 2011 patent expiration on its best-seller Actos (pioglitazone) for treating Type 2 diabetes. Takeda submitted data about the drug candidate at the end of 2007, but FDA said the information did not meet new standards adopted by the agency last year. (Click here for more
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