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Sun Pharma's cancer drug application gets EMA backing

Press Trust of India  |  New Delhi 

India's Sun Pharmaceutical today received recommendations from the European Medicines Agency for granting it marketing authorisation in the continent for cancer drug Doceferez, a generic version of French drugmaker Sanofi-Aventis' Taxotere.

The development comes at a time when Sun is up against a suit by in the US, alleging patent infringement and asking the US Food and Drug Administration not to grant approval to market it in America.

"The Committee for Medicinal Plants for Human Use (CMPH) adopted a positive opinion, recommending the grant of marketing authorisation for the medicinal product Doceferez, 20 mg and 80 mg powder and solvent concentration...," European Medicines Agency (EMA) said in a statement on its website.

The application was made by the European subsidiary of Sun Pharma, it added.

EMA said Dociferez has broad clinical anti-tumour activity against various types of cancer, such as lung, prostrate, gastric, head and neck.

Sanofi has been trying to protect its patent over the cancer drug, which by industry estimates generated sales of around $2.9 billion for the company last year.

First Published: Fri, February 19 2010. 22:32 IST