US FDA has rejected Schwarz Pharma's NDA for Rotigotine Transdermal System citing software issues. But the company is planning to re-file the NDA.
In a release, Schwarz Pharma said it had been informed by US FDA that the application in its present form was not acceptable. Reasons are software issues with the electronic new drug application (NDA). The European regulatory authorities have already accepted the electronic marketing authorization application (MAA).
Electronic applications for the Parkinson patch Neupro (rotigotine transdermal system) were submitted to both the US FDA and the European Medicines Evaluation Agency EMEA on September 29, 2004. The application was accepted by the EMEA and is undergoing review. FDA review revealed electronic and technical incompatibilities which impede the FDA from making a complete and accurate evaluation of Schwarz Pharma's NDA in a timely manner. Therefore the FDA did not accept the application in its present form.
Schwarz Pharma has identified the technical issues and expects a processing time of less than two months, the release added.
"To solve this issue we are working closely together with the FDA," comments Iris Loew-Friedrich, member of the executive board Schwarz Pharma AG. "We are confident that we can re-file in January. This gives us also the chance to maintain our original timelines for market launch," he added.
Neupro, with the active ingredient rotigotine, for the treatment of Parkinson's disease is a novel dopamine agonist formulated as a continuous transdermal delivery system, a patch.