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Supernus Pharmaceuticals Resubmits Marketing Application for Parkinson's Treatment Device
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Supernus Pharmaceuticals Resubmits Marketing Application for Parkinson's Treatment Device
Aug 2, 2024 3:52 AM

06:22 AM EDT, 08/02/2024 (MT Newswires) -- Supernus Pharmaceuticals ( SUPN ) said late Thursday that it has resubmitted a new drug application for its apomorphine infusion device, or SPN-830, developed to continuously treat motor fluctuations in Parkinson's disease.

The company said it had addressed the US Food and Drug Administration's concerns from an April 2024 Complete Response Letter, which requested additional information but did not raise clinical safety or efficacy issues.

It added that it would continue collaborating with the FDA during the review process.

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