Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer
Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.