Drug major Alembic Pharmaceuticals said that it has received a final approval from the US Food & Drug Administration (FDA) 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/m) of AstraZeneca Pharmaceuticals LP.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.
According to IQVIA, fulvestrant injection has an estimated market size of USD 71 million for twelve months ending September 2022.
The pharmaceutical company said that it has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from US FDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
