FDAnews
www.fdanews.com/articles/101675-ucb-files-nda-for-vimpat

UCB Files NDA for Vimpat

November 30, 2007
The FDA has accepted Belgian drugmaker UCB’s new drug application (NDA) for the use of Vimpat (lacosamide) in the treatment of adults with diabetic neuropathic pain.

 

In placebo-controlled trials of more than 800 people, sustained reductions in pain scores were seen versus placebo, according to UCB.

A similar filing made to the European Medicines Agency earlier this year is under review.