Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer.
The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement.
The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.
