scPharmaceuticals Inc. SCPH announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of the drug candidate FUROSCIX, for the treatment of congestion in patients with worsening heart failure.
The regulatory agency has set target action date of October 8, 2022
John Tucker, chief executive officer, said, "We believe FUROSCIX, if approved, will address a significant need along the heart failure care continuum. By providing a new option for the treatment of congestion related to heart failure, all stakeholders – patients, payers and providers – stand to benefit, and there is the potential to generate significant healthcare system cost savings".
The company is planning for a commercial launch in the fourth quarter of this year, if approved.
scPharmaceuticals is trading high 4.4 percent at $4.64
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