FDA Announces New Drug Application for Review


The most common side-effects of three Phase III randomized, double-blinded, placebo-controlled, 12-week maintenance trails were dizziness, somnolence, blurred vision, vomiting, nausea, headaches, fatigue, ataxia and vertigo. More than 1,300 patients with partial-onset seizures from around the world participated in this trial.

The original NDA of STEDESA® was submitted to the FDA in March 2009. Sunovion Pharmaceuticals prepared the current submission.



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