Mumbai: Pharma Major, Alembic Pharma on Monday said 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 September 2022, according to IQVIA.
