Dabur Pharma gets US approval for Irinotecan Hydrochloride injection

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Mumbai, Feb 29 (UNI) Dabur Pharma Ltd has announced the approval and launch of Irinotecan hydrochloride injection in United States.

Dabur Pharma CEO Ajay Kumar Vij in a release here said, ''the approval was a major milestone for the company. 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'' he said.

Irinotecan Injection is the generic version of Camptosar, which had sales of over 556 million dollar 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.


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