Mumbai: Dabur Pharma has launched `Irinotecan Hydrochloride injection', used mainly in treating rectum cancer, in the US.
Dabur said it has received FDA approval for marketing of Irinotecan injection, a generic version of Pfizer`s Camptosar, in the US.
Irinotecan is indicated as a component of first line therapy for patients with Metastatic Carcinoma (a form of cancer) of the colon or rectum. The drug is used in combination with 5- Fluorouracil and Leucovorin.
"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`s CEO Ajay Kumar Vij said in a filing with the Bombay Stock Exchange.
"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," he added.
Irinotecan is indicated for patients with Metastatic Carcinoma of the colon or rectum, where the disease has recurred or progressed following initial fluorouracil-based therapy, the release said.