Alembic Pharmaceuticals Ltd (Alembic) declared that its Abbreviated New Drug Application (ANDA) fluorouracil injection USP, 2.5 g/50 mL (50 mg/mL) pharmacy bulk vial has been given final FDA approval. The reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc., is therapeutically equivalent to the ANDA that has been approved (Spectrum). Patients with adenocarcinomas of the breast, colon, rectum, gastric, and pancreatic organs are recommended to receive fluorouracil injection as a treatment.
According to IQVIA, the market for fluorouracil injection USP, 2.5 g/50 mL (50 mg/mL) vial is expected to be worth US$ 5 million for the twelve months ending December 2022. Alembic has received 182 ANDA approvals from the US FDA overall (159 final approvals and 23 tentative clearances).
Since 1907, Alembic Pharmaceuticals Limited has been a leader in pharmaceutical research and development. The company is vertically integrated.
