Impax announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Rytary (carbidopa-levodopa). Rytary (formerly IPX066) is an extended-release capsule formulation of carbidopa-levodopa indicated for the symptomatic treatment of Parkinson‘s disease.
In the CRL, the FDA required a satisfactory re-inspection of the company’s Hayward facility as a result of the warning letter issued in May 2011 before approving the company’s NDA. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch.
Rytary is intended to maintain consistent plasma concentrations of levodopa for a longer duration vs. immediate release levodopa, which may have an impact on fluctuations in clinical response.
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