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Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The US FDA issued decisions on two new drug applications combining an on-body infusion device and an established drug last week. While the decisions went different ways – Supernus Pharmaceuticals, Inc.’s SPN-830 (apomorphine) received a complete response letter, while scPharmaceuticals, Inc.’s Furoscix (furosemide) was approved – the regulatory histories of both products showcase the challenges around manufacturing and device data faced by sponsors of drug-device combination products.

The approval of Furoscix in chronic heart failure patients on 7 October 2022, for example, came more than five years, two CRLs, and a switch in infusion pumps after

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