The US Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Application (ANDA) for the product
Image: Fulvestrant is used in treatment of definite advanced breast cancer in women. Photo: Courtesy of sutulo from Pixabay.
Generic and specialty pharmaceuticals company Mylan has launched its Fulvestrant Injection, a 250mg/5mL (50 mg/mL) per single-dose prefilled syringe, a generic version of AstraZeneca’s Faslodex Injection, in the US.
Fulvestrant is used in treatment of definite advanced breast cancer in women who have experienced menopause as monotherapy and in advanced or metastatic breast cancer in combination with other products.
Mylan has secured approval for its Abbreviated New Drug Application (ANDA) for the product from the US Food and Drug Administration (FDA).
Mylan president Rajiv Malik said: “Mylan’s launch of Fulvestrant Injection represents an important addition to our growing oncology portfolio and, more importantly, expands the available treatment options for women who are facing advanced or metastatic stages of breast cancer.
“The launch also reinforces our scientific expertise in bringing to market complex products, like injectables, which further enhances our institutional business and exemplifies our continued commitment to expanding access to medicine.”
Fulvestrant is used in treatment of definite advanced breast cancer in women
According to IQVIA, Mylan currently has 151 ANDAs pending FDA approval which reflects approximately $88.4bn (£70bn) in annual brand sales, and 44 of the pending ANDAs are potential first-to-file opportunities, representing $59.2bn (£47.5bn) in annual brand sales, for the 12 months ending June 30, 2019.
Mylan said that its Fulvestrant Injection is indicated as prescription medicine to treat women with Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or metastatic breast cancer.
The medicine is for patients who have gone through menopause, along with ribociclib as their first endocrine therapy or after their cancer has progressed while on prior endocrine therapy. It is also prescribed for HR-positive patients with HER2-negative advanced breast cancer, who have gone through menopause and untreated with endocrine therapy previously.
Fulvestrant Injection is a also prescription medicine used to treat women with HR-positive advanced breast cancer patients, who gone through menopause and disease has progressed after endocrine therapy, and HR-positive patients with HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib whose disease has progressed after endocrine therapy.