Dabur Pharma receives USFDA approval for generic Irinotecan

3480 Investors following Fresenius Kabi. Share this News with them.

0

Like this story, share it with millions of investors on M3

Dabur Pharma receives USFDA approval for generic Irinotecan

Dabur Pharma receives USFDA approval for generic Irinotecan

Post your opinion here

 

0

Tweet

Share on Tumblr

RELATED NEWS Accumulate Dabur India: Religare Dabur Pharma signs agreement with Combino Pharm Dabur expects 20% growth in oral care segment Dabur brand of soaps to be launched soon ALSO READ See latest News about Fresenius Kabi See previous management interviews See what other Experts & Brokerages are saying about Fresenius Kabi Fresenius Kabi BSE | NSE 25/05/12 Are Mutual Funds betting on Fresenius Kabi?

Dabur Pharma Ltd. (NSE: DABURPHARM, BSE: 532545), India's leading oncology player, today announced that the US Food and Drug Administration (USFDA) 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 said that it expects to begin marketing the drug in US upon expiry of the patent in February 2008.