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Alembic gets USFDA nod for Fulvestrant to treat breast cancer


HQ Team

December 26, 2022: Alembic Pharmaceuticals announced that it had 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 breast cancer treatment.

Fulvestrant injection, 250 mg/5 mL, has an estimated market size of $71 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.

Earlier in October, the USFDA inspected India’s Alembic Pharmaceuticals’ Oncology Injectable Formulation Facility at Panelav, Gujarat.

“The USFDA issued a Form 483 with four procedural observations. None of the observations is related to data integrity, and management believes they are addressable.”

An FDA Form 483 is issued to firm management after an inspection when an investigator has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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