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designated as a breakthrough therapy SPN-830 (Apomorphine Infusion Pump) Developer: Supernus/US WorldMeds/Brittania Modality: Small Molecule PDUFA Date: February 1, 2025 Indication/Description: Central nervous system disorders / Continuous subcutaneous infusion of the dopamine agonist apomorphine, used to treat motor fluctuations (OFF episodes) in adult Parkinson's disease patients Review Type: Standard Review Submission Date: August 1, 2024 Review Status: Experienced one RTF (Refuse to File) and two complete response letters

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