Dabur Pharma Ltd has announced that the US Food and Drug Administration (US FDA) has granted tentative approval to the company's Abbreviated New Drug Application (ANDA) to market it's generic version of Pfizer's Camptosar (Irinotecan Hydrochloride) injection 40mg and 100mg.
Irinotecan, which had sales of over US$ 500 million in the US (IMS - MAT 03/07), is indicated as a component of first line therapy in combination with 5- fluorouracil and leucovorin for the patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for the patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil- based therapy.
The company expects to begin marketing the drug in US upon expiry of the patent in February 2008, a Dabur press release stated.
Speaking on the occasion, Ajay Kumar Vij, CEO, of the company said that "this marks a major milestone Dabur Pharma, which is vertically integrated in the product and is already one of the largest producers of irinotecan API (Active Pharmaceutical Ingredient) in the world. The company is one of the most cost effective producers of Irinotecan in the world and the approval & subsequent launch will provide a quantum jump to our aggressive growth plans".