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26th December, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today 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. Refer to our label for full indication.
Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US$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.