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

Contact Us

501-227-5061 Phone
501-227-5234 Fax
888-527-5061 Toll Free

#2 Lile Court Suite 100
Little Rock, Arkansas 72205
srhichens@practice-plus.com

Little Rock Office Location