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FDA delays decision on Actemra approval


NEW YORK The Food and Drug Administration put off a decision to approve Chugai Pharmaceutical’s rheumatoid arthritis drug Actemra. Following the news, the company’s stock value decreased by 8.3 percent on the Tokyo Stock Exchange.

Chugai filed its approval application with the FDA in November of last year, but the FDA declined to approve it in September, requesting more production and labeling data.

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