11:02 AM
Jun 13, 2018
 |  BC Extra  |  Company News

FDA wants more info on scPharmaceuticals’ Furoscix

scPharmaceuticals Inc. (NASDAQ:SCPH) dropped $1.68 (22%) to $5.93 Wednesday after it received a complete response letter from FDA for an NDA for Furoscix (scFurosemide) to treat edema in patients with heart failure.

scPharmaceuticals said the letter indicated that additional human factors studies and device modifications were needed and that a clinical validation study may also be required. The company plans to request a meeting with the agency.

The application was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products.

The company received a letter in May from FDA citing unspecified deficiencies in the NDA.

Furoscix is a subcutaneous formulation of the diuretic furosemide delivered via the company's sc2Wear Infusor.

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