FDA Approves Generic Fulvestrant Injection for Advanced Breast Cancer

Officials from the FDA have given final approval to Glenmark Pharmaceuticals’s Abbreviated New Drug Application (ANDA) for fulvestrant injection, in 250mg/5mL dose, as a monotherapy for women’s advanced breast cancer. ¹

The newly approved therapy is equivalent to AstraZeneca Pharmaceuticals’ Faslodex injection, 250mg/5mL.¹

Fulvestrant injection is indicated to help women with advanced breast cancer who have gone through menopause or have not received previous endocrine therapy. It is also indicated to target untreated, hormone receptor-positive advanced breast cancer before the disease advances. ²

According to Glenmark, the fulvestrant injection had annual sales of about $549.9 million over a 12-month period, as indicated by IQVIA data. ¹

References

• Glenmark pharmaceuticals receives ANDA approval for Fulvestrant injection, 250 mg/5 mL (50 mg/mL) [news release]. Mumbai, India; August 23, 2019: Glenmark Pharmaceuticals Newsroom. https://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Fulvestrant-Injection-250-mg-5-mL_0.pdf. Accessed August 23, 2019.
• Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer [news release]. August 29, 2017: AstaZeneca website. https://www.astrazeneca.com/investor-relations/stock-exchange-announcements/2017/faslodex-receives-us-fda-approval-as-monotherapy-for-expanded-use-in-breast-cancer-28082017.html. Accessed August 23, 2019.