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Impax Parkinson’s Therapy Suffers Manufacturing Setback During FDA Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA dealt Impax Pharmaceuticals a “complete response” for its extended-release carbidopa/levodopa therapy for spasms suffered by Parkinson’s disease patients, rejecting the drug combo based on unresolved manufacturing issues at the firm’s Hayward, Calif., plant, though Impax has said it will manufacture the product, now called Rytary, exclusively at its Taiwan facility.

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