As an update to our blog post this past October, Michael J. Fox Foundation awardee Impax Pharmaceuticals (Impax) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding their new drug application (NDA) of Rytary, or IPX066, an extended-release capsule formulation of carbidopa-levodopa, a potential symptomatic treatment for Parkinson’s disease patients. 

Complete response letters are issued by the FDA’s Center for Drug Evaluation and Research when the review cycle for a drug is complete and the application is not yet ready for approval. In the case of Rytary, the FDA issued a complete response letter as they require a satisfactory re-inspection of Impax’s facility in Hayward, California before the company’s NDA of Rytary may be approved. Impax President and CEO, Larry Hsu, PhD said of the FDA complete response letter:

“We remain committed to resolving the warning letter and bringing this new treatment option to patients who are suffering from Parkinson’s disease… We will work with the FDA on the appropriate next steps for the Rytary application.”

We will closely monitor developments in relation to Impax’s NDA and share updates as they become available.