scPharmaceuticals Inc. Provides Regulatory Update

scPharmaceuticals Inc. (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 that, on May 30, 2018, the Company received a letter from the U.S. Food and Drug Administration (FDA) as part of the FDA’s ongoing review of the Company’s New Drug Application (NDA) for FUROSCIX® Infusor (furosemide) 80 mg/10mL, drug-device combination product. The letter states that the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The letter further states that the notification does not reflect a final decision on the information under review.

The FDA’s letter does not specify the deficiencies identified as part of its ongoing review.  The Company intends to work with the FDA to understand the nature of the deficiencies once identified and resolve them as quickly as possible.

In a prior FDA communication on September 14, 2017, the FDA had set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 23, 2018 to complete its review of the NDA.

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