Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.
FDA approves Supernus’ Onapgo to treat advanced Parkinson’s …
2 days ago · The US Food and Drug Administration (FDA) has approved Supernus Pharmaceuticals’ Onapgo (apomorphine hydrochloride) injection to treat motor fluctuations in adults with advanced Parkinson’s disease (PD). Almost one million people in the US are living with PD, a progressive neurodegenerative disorder that can cause tremors, muscle rigidity, involuntary movements, and difficulty with ...
Supernus Pharmaceuticals Announces FDA Approval of ONAPGO, …
2 days ago · Supernus Pharmaceuticals has announced the FDA approval of ONAPGO, the first subcutaneous apomorphine infusion device specifically designed to treat motor fluctuations in adults with advanced ...
SPN-830, now Onapgo, approved for advanced Parkinson’s disease
3 days ago · Long road to Onapgo’s approval Despite these demonstrated benefits, Supernus has faced challenges in getting the therapy approved by the FDA. The company first applied for SPN-830’s approval in 2020, but regulators said the application lacked sufficient data for review.
Supernus wins FDA approval for Parkinson’s pump on fourth try
1 day ago · Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson’s disease. Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval.
US approves "milestone" Parkinson's treatment for 2025 release
2 days ago · Developed by Supernus Pharmaceuticals, Onapgo does away with the hassle of needing to administer constant injections.
Supernus Announces FDA Approval of ONAPGO ... - Markets Insider
2 days ago · Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.
Supernus Gets FDA Approval of Onapgo Device for Parkinson's …
2 days ago · Supernus Pharmaceuticals has won Food and Drug Administration approval for its Onapgo device to treat patients with Parkinson's disease. Supernus on Tuesday said the FDA green light makes Onapgo ...
Supernus' Parkinson's pump Onapgo finally lands FDA approval
3 days ago · Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump. On its fourth attempt to pass muster with the FDA, the company’s SPN-830, now ...
Supernus wins FDA approval for ONAPGO, a continuous infusion …
3 days ago · Supernus Pharmaceuticals plans to launch ONAPGO in the second quarter of 2025, alongside a patient support program aimed at enhancing accessibility and treatment adherence. How Does ONAPGO Improve Parkinson’s Disease Management? For patients with advanced Parkinson’s disease, managing motor fluctuations remains a persistent challenge.
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