HQ Team
March 6, 2023: Alembic Pharmaceuticals has received approval from the US Food & Drug Administration to market a generic drug to treat cancer, the drug firm said in a statement.
The drug, Fluorouracil Injection, is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma. The 2.5 g/50 mL (50 mg/mL) vial of the injection has an estimated market size of USD 5 million in the US market.
The approved product is therapeutically equivalent to Spectrum Pharmaceuticals Inc‘s product. Alembic said it now has a cumulative 182 abbreviated new drug application (ANDA) approvals from the USFDA.
The company revealed recently that it will be accounting for an impairment charge of Rs 1,150 crore for three of its under-construction manufacturing facilities, which drove its share prices lower. The company’s total write-off now stands at Rs 1,490 crore, which includes Rs 340 crore of write-off due to the buyout of its partner stake Aleor Derma in March last year.
