scPharmaceuticals Inc. Receives Complete Response Letter from FDA for FUROSCIX®
scPharmaceuticals Inc. (SCPH)
Last scpharmaceuticals inc. earnings: 3/24 07:00 am
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scpharmaceuticals.com
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Source: GlobeNewswire
BURLINGTON, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (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 it received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) on December 3, 2020 regarding the Company’s New Drug Application (“NDA”) for FUROSCIX®. In the CRL, the FDA cited their need to conduct pre-approval inspections at two of the company’s third-party manufacturing facilities that could not be conducted due to travel restrictions. In addition, the FDA raised questions related to testing, labeling, and features of the combination product unrelated to the drug constituent. In addition, the FDA indicated that there were deficiencies at the third-party facility where the Company’s off-the-shelf alcohol swabs are manufactured. scPharmaceuticals
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SCPH
News
- scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) InjectionGlobeNewswire
- scPharmaceuticals Inc. (NASDAQ: SCPH) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $18.00 price target on the stock.MarketBeat
- scPharmaceuticals Inc. (NASDAQ:SCPH) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business UpdateGlobeNewswire
- scPharmaceuticals to Announce Fourth Quarter and Full-Year 2023 Financial Results on Wednesday, March 13, 2024GlobeNewswire
SCPH
Earnings
- 3/13/24 - Beat
SCPH
Analyst Actions
- 3/18/24 - HC Wainwright
SCPH
Sec Filings
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- 4/12/24 - Form PRE
- SCPH's page on the SEC website