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FDA Declines To Approve Supernus Pharma's Parkinson's Drug

Por: RTTNews Health October 10, 2022

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The FDA has declined to approve Supernus Pharmaceuticals Inc.'s () SPN-830, an apomorphine infusion pump, proposed for the continuous treatment of motor fluctuations, i.e., OFF episodes, in Parkinson's disease.In the Complete Response letter, issued today, the FDA has asked the company for additional information and analysis related to the infusion device and drug product across several areas, including labeling, product quality and... + full article



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