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Wednesday, November 29, 2023

Alembic Pharma receives USFDA final approval for Fluorouracil Injection


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Mumbai: Alembic Pharma on Monday said it has received 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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 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 full indication.

Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated market size of US$ 5 million for twelve months ending Dec 2022 according to IQVIA.


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