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Another US approval delay for Takeda

This article was originally published in Scrip

Executive Summary

Takedahas suffered a US approval delay for another of its products, this time the proton pump inhibitor dexlansoprazole (TAK-390MR). The US FDAwould not be able to complete its review by the original Prescription Drug User Fee Act date in October, and this was now expected to take a further three months, the Japanese firm said. Its DPP-4 inhibitor alogliptin recently suffered a similar delay and now looks unlikely to be approved before the end of the year (Scrip Online, October 10th, 2008). Dexlansoprazole, a modified once-daily form of lansoprazole, was filed in December 2007 for treating the symptoms of gastro-oesophageal reflux disease and healing/maintenance use in erosive oesophagitis.

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