Sepracor To Meet With FDA After Complete Response Letter For Epilepsy Drug Stedesa
This article was originally published in The Pink Sheet Daily
Agency had extended the review of the seizure therapy by three months, but still needs additional information.
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Daiichi Sankyo, Shionogi Profits Increase; Dainippon Sumitomo Expands In China - Japanese Pharma Earnings Roundup (Part 2 Of 2)
Major Japanese pharma face many of the same problems as major Western pharma, including patent cliffs and growth slowdown in traditional markets. Japanese pharma, on the other hand, have been slower to establish themselves in emerging markets. But that may soon be changing, as can be seen in this Japanese pharma earnings roundup, a periodic feature in PharmAsia News. Part one of this roundup looked at the approaches Astellas and Eisai are taking to deal with major patent losses (PharmAsia News, May 25, 2010).
Late 2008/early 2009 NDA filing targeted for the new chemical entity as an adjunct therapy to improve control of epileptic seizures.