USFDA approves Alembic Pharmaceuticals’ Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe Kumar Jeetendra | December 26, 2022 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), …
