December 11, 2020
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The Marketing Authorization of CTTQ’s Fulvestrant Injection was issued on December 19, 2019 by the Federal Institute for Drugs and Medical Devices (BfArM) of Germany, while the Abridged New Drug Application (ANDA) was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2020.
Fulvestrant, as a novel estrogen receptor antagonist, can block the nutrition of estrogen. It is indicated for the treatment of Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
As a significant milestone of internationalization, the export of Fulvestrant Injection to EU and US will facilitate CTTQ’s expansion into international market. According to the clinical need, CTTQ will develop more products with technology or production barriers, and constantly supply global market with reliable quality.
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