Sandoz today announced that the first generic Fulvestrant Injection has been approved by the US Food and Drug Administration (FDA) and is immediately available in the US.
It is a fully substitutable AP rated generic version of AstraZeneca’s FASLODEX (fulvestrant) Injection.
This hormonal therapy medicine is recommended for the three quarters of women with advanced breast cancer whose tumor expresses the estrogen receptor (ER), and slows tumor growth by binding to and blocking the ER, a key driver of disease progression1.
‘Fulvestrant is an important treatment option for women with advanced breast cancer and we will work to help those in the US who need this critical therapy have access to it at an affordable price,’ said Carol Lynch, President of Sandoz Inc. ‘This treatment fits well with our ongoing strategic focus on oncology, where Sandoz has substantial experience bringing important oncology medicines to hospitals, clinics, doctor’s offices and patients in the US.’
According to IQVIA, US sales for FASLODEX (fulvestrant injection) for the 12-month period ending March 2019 were USD 541 million (MAT: Moving Annual Total).
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