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FDA Approves Onapgo - Drugs.com
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. “Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe, where it has helped deliver more consistent control of motor ...
Supernus Announces FDA Approval of ONAPGO™ (apomorphine …
1 day ago · Supernus Pharmaceuticals, Inc. ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
SPN-830, now Onapgo, approved for advanced Parkinson’s disease
2 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.
FDA approves Supernus’ Onapgo to treat advanced Parkinson’s …
19 hours 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 ...
Supernus Announces FDA Approval of ONAPGO ... - Markets Insider
1 day ago · 1 ONAPGO. Package insert. Supernus Pharmaceuticals, Inc. *Efficacy results from the analysis of data from the TOLEDO study using the FDA’s preferred methodology, mixed-effects model for repeated ...
Supernus Pharmaceuticals Announces FDA Approval of ONAPGO, …
1 day 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.
U.S. FDA approves Supernus' drug-device combination for …
1 day ago · The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat movement-related symptoms of Parkinson's disease, the drugmaker said on Tuesday.
FDA Approves Apomorphine Infusion Device SPN-830 as New …
2 days ago · Nearly 4 and a half years since its original submission, the FDA has approved Supernus Pharmaceuticals’ investigational agent SPN-830 (Onapgo) as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD).
Supernus' Parkinson's pump Onapgo finally lands FDA approval
1 day ago · Onapgo is a wearable pump designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). ... Supernus’ Apokyn contributed $19.9 million to the company’s total ...
Supernus Gets FDA Approval of Onapgo Device for Parkinson's …
1 day ago · Supernus said Onapgo is a wearable infusion device that provides continuous treatment during the waking day for more consistent control of off periods, which can occur in people with Parkinson's ...
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