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Drug firm says Avastin got approval in Feb

(chinadaily.com.cn)
Updated: 2010-11-23 06:04

SHANGHAI - Shanghai Roche Pharmaceuticals Ltd., Swiss pharmaceutical company Roche's first joint venture in China, announced in October that its drug Avastin has been approved for sales on the Chinese mainland.

The announcement came after Shanghai Food and Drug Supervision Administration's report in late September that the drug was suspected of causing adverse reactions in 61 patients at the Shanghai No 1 People's Hospital, where 116 patients have received Avastin injections for macular degeneration, a type of eye disease.

Avastin received approval from China's State Food and Drug Administration in February for use on the Chinese mainland, but it has not yet been officially sold in the Chinese market. Meanwhile, the drug was approved only for treatment of metastatic colorectal cancer.

Later investigation found that the drug given to the patients was not the real Avastin, but was labeled as a Roche manufactured product with batch number B6001B01. And a number of suspects involved in the selling of fake eye drug have been detained.

Still, media reported that the drug was still in wide use for treating macular degeneration, and the macular deterioration procedure has been performed in over 30 hospitals, which was questioned by many patients who have used this drug.