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.

FULL ARTICLE:

http://www.epilepsyfoundation.org/resources/newsroom/pressreleases/FDA-Announces-New-Drug-Application-for-Review.cfm