Dabur Pharma Ltd has announced that it has received US FDA approval for irinotecan hydrochloride injection and launched in the United States.
Speaking on the occasion, Ajay Kumar Vij, CEO said, "This is a major milestone for Dabur Pharma. This is our 4th product approval in the US market, wherein we have already submitted 13 dossiers. Dabur Pharma is vertically integrated in the product and is already one of the largest producers of Irinotecan API (Active Pharmaceutical Ingredient) in the world. The approval in US will provide a quantum jump to our aggressive growth plans".
Irinotecan Injection is the generic version of Camptosar, which had sales of over US $556 million in the US (IMS - MAT 03/07). Irinotecan is indicated as a component of first line therapy in combination with 5- fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil- based therapy.