Category: Approval/Launch Region: Asia · India Company: Alembic Pharmaceuticals Ltd

Alembic Pharma receives USFDA nod for Fulvestrant Injection

Alembic Pharma receives USFDA nod for Fulvestrant Injection
Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer Alembic Pharmaceuticals Limited 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.

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