FDA declines to approve Dainippon’s epilepsy drug

Last fall, when Dainippon Sumitomo Pharma announced that it had inked a deal to buy Sepracor for $2.6 billion, the Japanese pharma company cited the once-daily epilepsy drug Stedesa as one of the near-term drug prospects it was most excited about. Yesterday afternoon, though, the FDA declined to approve Stedesa, and now Dainippon is attempting to sort out what steps it will have to take next. Dainippon didn't spell out exactly what the FDA discussed in its complete response letter. And a...