Schwarz Pharma has re-submitted the revised New Drug Application (NDA) for rotigotine transdermal system to the US FDA on Friday, January 28, 2005. The FDA had not accepted the application form due to electronic issues.
"Schwarz Pharma worked closely with FDA to address their concerns with the electronic formatting of the NDA," comments Iris Loew-Friedrich, Member of the Executive Board Schwarz Pharma AG responsible for research and development.
Electronic applications for rotigotine transdermal system were submitted to both the US FDA and the European Medicines Evaluation Agency (EMEA) on September 29, 2004. While the application form was accepted by the EMEA, the FDA refused to accept the form due to electronic issues.
Rotigotine has been formulated as a transdermal delivery system, a patch.