scPharmaceuticals Receives Complete Response Letter from the FDA for FUROSCIX

- June 13th, 2018

scPharmaceuticals (Nasdaq:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care and reduce healthcare costs, today announced the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the 505(b)(2) application for FUROSCIX®, a treatment … Continued

scPharmaceuticals (Nasdaq:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care and reduce healthcare costs, today announced the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the 505(b)(2) application for FUROSCIX®, a treatment candidate for edema, or fluid overload, in patients with heart failure.

As quoted in the press release:

The CRL indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study. scPharmaceuticals intends to request a meeting with the FDA to further evaluate the deficiencies raised.

“While we are disappointed with the outcome of the review, we are committed to addressing the issues of the CRL and bringing this important product to market,” commented John Tucker, president and chief executive officer of scPharmaceuticals. “Our team will continue to work closely with the FDA to determine an appropriate path forward regarding product performance, appropriate patient identification, and risk mitigation strategies that ultimately enable a timely resubmission of the FUROSCIX NDA.”

Click here to read the full press release.

Are You Aware of the FDA's Plans for 2018?

Find out what's going on in our new report
 

Leave a Reply

Your email address will not be published. Required fields are marked *