Basilea gets a HANDEL on potential US filing for Toctino
This article was originally published in Scrip
Executive Summary
Basilea Pharmaceutica said it plans to meet with the US FDA in the second half of the year to discuss final Phase III data and the necessary requirements for a risk evaluation and mitigation strategy (REMS) for its hand eczema treatment Toctino (alitretinoin) as it gears up for a new drug application (NDA) filing.