Alembic Pharmaceuticals acquired final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The accredited ANDA is therapeutically equal to the reference listed drug product (RLD), Fluorouracil Injection, 2.Five g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum). Fluorouracil Injection is indicated for the treatment
of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma. Refer to our label for complete indication.

Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated marketplace length of US$ 5 million for three hundred and sixty five days ending Dec 2022 in step with IQVIA.