Alembic Pharmaceuticals Limited on Monday 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.
According to a press statement, 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.
According to IQVIA, AFulvestrant Injection, 250 mg/5 mL, has an estimated market size of US$71 million for twelve months ending September 2022.
Alembic Pharmaceuticals has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.
