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www.fdanews.com/articles/131368-despite-complete-response-letter-arena-remains-optimistic-about-lorcaserin

Despite Complete Response Letter, Arena Remains Optimistic About Lorcaserin

October 26, 2010
Drugmakers developing prescription weight-loss drugs have a high hurdle to gain agency approval if the FDA’s action letter to Arena Pharmaceuticals regarding its lorcaserin NDA is any indication. The FDA issued Arena a complete response letter Friday, indicating the company will need to supply additional nonclinical and clinical data to have its application approved. Arena said the nonclinical issues are carcinogenicity concerns related to findings of malignant tumors in rats observed in pre-clinical studies.
Drug Industry Daily