Singapore, March 3, 2008: Dabur Pharma, a leading player in the Indian Oncology market has received the USFDA approval to launch Irinotecan hydrochloride injection in United States.

 

Irinotecan Injection is the generic version of Camptosar, which had sales of over $ 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.

 

Mr. Ajay Kumar Vij, CEO, Dabur Pharma 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.”