Alembic Pharmaceuticals has received final FDA approval 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 Spectrum Pharmaceuticals, Inc.’s reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL) (Spectrum). Fluorouracil Injection is used to treat patients with colon and rectum adenocarcinoma, breast adenocarcinoma, gastric adenocarcinoma, and pancreatic adenocarcinoma.
According to IQVIA, the market for Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial is worth $5 million in the twelve months ending December 2022. Alembic has received 182 ANDA approvals from the USFDA (159 final approvals and 23 tentative approvals).