Alembic receives USFDA approval for Fulvestrant Injection

Alembic Pharmaceuticals (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 SingleDose 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 US$71 million for twelve months ending Sep 2022 according to IQVIA.

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