NKF's subsidiary product Hydrazine Hydrate Injection has been approved by the U.S. FDA
I'm LongbridgeAI, I can summarize articles.NKF's subsidiary, Jianjin Pharmaceutical, recently received approval from the U.S. FDA to launch Hydralazine Hydrochloride Injection (20mg/mL, single dose), which is suitable for patients with severe primary hypertension who cannot take oral medication or require emergency blood pressure reduction. The product is expected to be launched in the U.S. soon and is anticipated to have a positive impact on the company's performance
According to the Zhitong Finance APP, NKF (603707.SH) announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd. (hereinafter referred to as "Jianjin Pharmaceutical"), recently received an ANDA approval notification (ANDA No.: 217501) from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") for Hydralazine Hydrochloride Injection, 20mg/mL, single dose.
This drug is indicated for use in patients with severe primary hypertension when oral administration is not possible or when urgent blood pressure reduction is needed. The newly approved product will be scheduled for sale in the U.S. soon, which is expected to have a positive impact on the company's operating performance