I'm not sure if this was commented on previously. However, for those interested, Impax Labs has resubmitted their NDA for Rytary, which is extended release levodopa-carbidopa. The application has been accepted by the FDA and they will respond on or before Oct 9. The company has stated that if approved, they hope to begin selling the drug in the first quarter of 2015.

To recap a little of the history behind Impax's L/C ER saga,the drug received provisional FDA approval two years ago. However, they were never given final approval due to numerous and serious problems and violations at their Hayward manufacturing facility. They made several attempts at solving the problems but have continuously failed. It got so bad that GSK walked away from a international distribution contract costing Impax $175 million.

Well, they now think that the manufacturing facility will be approved. In the efficacy trials, patients did have significantly less off-time when taking the extended release version of L/C.

http://seekingalpha.com/article/2185...nscript?page=1