scPharmaceuticals Announces Feedback From Two FDA Meetings Related To The Development Of An 80mg/1mL Auto-Injector
Portfolio Pulse from Benzinga Newsdesk
scPharmaceuticals has received feedback from two FDA meetings regarding the development of an 80mg/1mL auto-injector. The company is planning to expand the FUROSCIX franchise to include this auto-injector as an additional delivery system for heart failure patients. The FDA has confirmed that no additional clinical data is required to pursue label expansion of FUROSCIX into chronic kidney disease (CKD).
September 19, 2023 | 12:13 pm
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scPharmaceuticals' plans to expand the FUROSCIX franchise with an 80mg/1mL auto-injector and the FDA's confirmation of no additional data requirement for label expansion into CKD could potentially boost the company's stock.
The development of a new delivery system for FUROSCIX and the potential label expansion into CKD could increase the product's market reach and sales, which could positively impact scPharmaceuticals' revenues and stock price.
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