Heron Pharma’s First US DMF-Regadenoson DMF036679
Jan. 24th, 2022, US Food and Drug Administration acknowledged receipt of the following Drug Master File (DMF) submission:
DMF Number Assigned: 036679
Date of Submission: January 24, 2022
Subject (Title): Regadenoson
Holder: Nanjing Heron Pharmaceutical Co., Ltd.
This is the first US DMF No. Heron Pharma earned. Oct. 26th, 2021, the First-imitation drug of Heron Pharma was approved by NMPA - Regadenoson Injection, which is applied to the diagnosis of myocardial ischemia. The approval number "NMPN H20213800" fills the vacancy of myocardial perfusion imaging (MPI) loading drugs in China.
Heron Pharma was established in March 2013. In the same year, Regadenoson injection project was initiated and obtained the major scientific and technological special support of the 13th five-year plan for "Significant New Drugs Development" (subject No. 2019ZX09302001). The clinical research was jointly led by Academician Ge Junbo and Professor Shi Hongcheng of Zhongshan Hospital Affiliated to Fudan University, and 12 clinical centers were involved in commanded by Academician Han Yaling, Shenyang Military Region General Hospital of the People's Liberation Army. Eight years late, as the world's first generic drug, this approval brought more choices for China’s patients with cardiovascular diseases.
The original drug of Regadenoson Injection was approved by US FDA in 2008. More than 84% patients who need radionuclide myocardial perfusion imaging through drug load (alone or combined movement) were diagnosed with this drug. Because of the emergent unmet clinical need, Regadenoson injection has been listed in the latest edition of China's Guideline for the Diagnosis and Treatment of Stable Coronary Heart Disease and Clinical Application Guideline of Radionuclide Myocardial Imaging, Edition 2018.
Post time: Mar-07-2022