Alembic Pharma gets USFDA nod for Fulvestrant injection, 250 mg/5 mL per single-dose syringe

Alembic Pharmaceuticals 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.

Fulvestrant injection, 250 mg/5 mL, has an estimated market size of $71 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.