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 ...
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 ...
Supernus Announces FDA Approval of ONAPGO ... - Markets Insider
3 days 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 Announces FDA Approval of ONAPGO™ (apomorphine …
3 days 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
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 Pharmaceuticals Announces FDA Approval of ONAPGO, …
3 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.
U.S. FDA approves Supernus' drug-device combination for …
3 days 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.
Onapgo FDA Approval History - Drugs.com
3 days ago · Onapgo FDA Approval History. Last updated by Judith Stewart, BPharm on Feb 4, 2025.. FDA Approved: Yes (First approved February 4, 2025) Brand name: Onapgo Generic name: apomorphine hydrochloride Dosage form: Infusion Device Previous Name: SPN-830 Company: Supernus Pharmaceuticals, Inc. Treatment for: Hypomobility in Parkinson’s Disease Onapgo (apomorphine hydrochloride) is a continuous ...
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.
Supernus' Parkinson's pump Onapgo finally lands FDA approval
3 days 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 ...
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