Alembic Pharma gets USFDA nod for generic cancer drug

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26 Aug, 2025 12:21

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Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic drug to treat cancer.

The company has received approval from the US Food & Drug Administration (USFDA) for Fluorouracil Injection, the drug firm said in a statement.

The approved product is therapeutically equivalent to Spectrum Pharmaceuticals Inc's product.

Fluorouracil injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.

According to IQVIA data, Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) vial, has an estimated market size of USD 5 million in the US market.

Alembic said it now has a cumulative 182 abbreviated new drug application (ANDA) approvals from the USFDA.