On Monday, Alembic Pharmaceuticals announced that its Fulvestrant injectable, which is used to treat breast cancer, has gained final approval from the US health agency.
As per Moneycontrol, the US Food and Drug Administration (USFDA) has granted approval for the abbreviated new drug application (ANDA) for Fulvestrant injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, according to a company release.
The approved injectable is therapeutically equal to AstraZeneca Pharmaceuticals LP’s Faslodex Injection, the reference listed drug product (RLD).
According to the manufacturer, fulvestrant injection is an estrogen receptor antagonist approved for the treatment of breast cancer.
Fulvestrant injection, 250 mg/5 mL, had an expected market size of USD 71 million for the 12 months ending September 2022, the business said, citing IQVIA data.
